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Showing 23 Sharing Your Opinions jobs in Canada
Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
The HR Shared Services Specialist is responsible for the administration, coordination, and support of Canadian employee benefit programs and leave management processes. This role serves as a key point of contact for employees, managers, vendors, and HR partners, ensuring the accurate and timely administration of health and welfare benefits, pension plans, disability programs, leaves of absence, and time-off programs. The Specialist delivers exceptional employee service while ensuring compliance with applicable legislation, company policies, and plan requirements.
Responsibilities may include the following and other duties may be assigned.
+ Provides centralized human resource administration and support across a variety of processes and programs including Global Rewards, Global Talent & Leadership Development, Global HR Operations and Employee Relations.
+ Collaborates across the Human Resources function to establish operational standards and procedures that are leveraged to respond to employee and manager questions, ensures transactions are processed accurately and human resource programs and processes are administered effectively and efficiently.
+ Leads & participates in internal and cross-functional initiatives related to continuous process and quality improvement initiatives (such as Lean or Six Sigma).
+ Identifies customer-impacting issues and implement solutions and process improvements to increase customer experiences.
+ Ensures streamlined human processes, workflows, metrics, and system optimization.
+ Helps to define requirements for systems that will facilitate increased efficiencies, automation and/or self-service for various HR processes.
+ May also create test plans, lead testing cycles, and configure systems.
+ Provides segmented professional support to VPs and managers or employees during moments that matters with the ability to emphasize with the customer and apply discretion where needed in interactions with customers.
+ Functional Skills: HR Program Administration, HR Policies, Human Resources Information Systems, Data Analysis, Knowledge Management.
+ Additional Skills: Problem Solving, Detail Oriented, Cross-Functional, Collaboration, Customer Service, Process Improvement, Communication.
**Key Responsibilities in Canada:**
**Benefits Administration**
+ Administer Canadian health and welfare benefit programs, including medical, dental, vision, life insurance, accidental death and dismemberment (AD&D), and other employee benefit offerings.
+ Support employee benefit enrollments, changes, terminations, and beneficiary updates in accordance with plan rules and service level agreements.
+ Support annual benefits enrollment activities and employee communications.
+ Coordinate with third-party benefit providers and brokers to resolve eligibility, claims, and coverage issues.
+ Audit benefit data and transactions to ensure accuracy and compliance.
**Pension Administration**
+ Support the administration of Canadian pension and retirement savings programs, including defined contribution and/or defined benefit plans.
+ Process employee enrollments, terminations, transfers, and retirement-related transactions.
+ Coordinate with pension administrators and vendors to ensure timely and accurate recordkeeping.
+ Respond to employee inquiries regarding pension plan provisions and retirement savings options.
**Disability and Leave Management**
+ Administer short-term disability, long-term disability, workers' compensation, and other income replacement programs.
+ Coordinate leave of absence processes, including medical, parental, maternity, paternity, bereavement, personal, and other statutory or company-sponsored leaves.
+ Maintain regular communication with employees, managers, payroll, and external vendors throughout the leave lifecycle.
+ Monitor leave cases and ensure required documentation is received and maintained.
**Time-Off Administration**
+ Administer vacation, sick leave, personal days, and other paid and unpaid time-off programs.
+ Ensure accurate tracking and reporting of employee leave balances.
+ Support managers and employees with time-off policy interpretation and system-related inquiries.
**Employee Support and Service Delivery**
+ Serve as the escalated point of contact for employee inquiries related to benefits, pensions, disability programs, leaves of absence, and time-off policies.
+ Provide accurate and timely responses through HR service delivery channels while maintaining confidentiality of sensitive employee information.
+ Escalate complex cases as appropriate and collaborate with internal stakeholders to resolve issues.
**Compliance, Reporting, and Continuous Improvement**
+ Ensure compliance with federal and provincial employment standards, pension regulations, privacy legislation, and company policies.
+ Maintain accurate employee records and documentation within HRIS and case management systems.
+ Generate and analyze reports related to benefits, leaves, and pension administration.
+ Identify opportunities to improve processes, enhance employee experience, and increase operational efficiency.
+ Participate in system testing, process documentation, audits, and HR projects as required.
**Key Competencies**
+ Customer Focus
+ Attention to Detail
+ Accountability
+ Collaboration
+ Problem Solving
+ Communication
+ Adaptability
+ Process Improvement
+ Time Management
**Required Qualifications**
+ Must be located in Canada and be fully bilingual in **French** and English (written and verbal).
+ Demonstrated experience administering and supporting employee benefits programs, including health and welfare plans, pension programs, and disability/leave of absence management.
+ Strong ability to work independently, manage competing priorities, and adapt effectively in a dynamic and evolving environment.
**Preferred Qualifications**
+ Experience working with benefits and HR platforms, including Workday, CNESST, and Manulife.
+ Familiarity with Canadian benefits administration processes, regulations, and vendor management.
+ Proven ability to navigate complex employee benefit and leave-related inquiries while delivering a high level of service.
**Salary Range: $64000 - $8000**
**PLEASE NOTE:**
+ We use artificial intelligence (AI) to review resumes of candidates and assess their fit based on the criteria outlined in the job posting. We do not use AI to make any final hiring or interview decisions.
+ This posting reflects a current, genuine vacancy that we are actively recruiting to fill
**PHYSICAL JOB REQUIREMENTS**
+ _The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers._
Medtronic Canada strives through our vision to build a culture of inclusiveness through our commitment to employment equity and diversity. Discrimination is prohibited on any grounds protected under Canadian Human Rights legislation. Employment applications are encouraged from all members of our community. Upon request, candidates with disabilities will be accommodated during the recruitment process.
**SPECIALIST CAREER STREAM:** Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
**DIFFERENTIATING FACTORS**
**Autonomy:** Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.
**Organizational Impact:** Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones.
May have some involvement in cross functional assignments.
**Innovation and Complexity:** Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex.
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
**Communication and Influence:** Communicates primarily and frequently with internal contacts.
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
**Leadership and Talent Management:** May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
**Required Knowledge and Experience:** Requires 2+ years of experience with a high school diploma or equivalent or advanced degree with 0 years of experience.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
**A Day in the Life**
The HR Shared Services Specialist is responsible for the administration, coordination, and support of Canadian employee benefit programs and leave management processes. This role serves as a key point of contact for employees, managers, vendors, and HR partners, ensuring the accurate and timely administration of health and welfare benefits, pension plans, disability programs, leaves of absence, and time-off programs. The Specialist delivers exceptional employee service while ensuring compliance with applicable legislation, company policies, and plan requirements.
Responsibilities may include the following and other duties may be assigned.
+ Provides centralized human resource administration and support across a variety of processes and programs including Global Rewards, Global Talent & Leadership Development, Global HR Operations and Employee Relations.
+ Collaborates across the Human Resources function to establish operational standards and procedures that are leveraged to respond to employee and manager questions, ensures transactions are processed accurately and human resource programs and processes are administered effectively and efficiently.
+ Leads & participates in internal and cross-functional initiatives related to continuous process and quality improvement initiatives (such as Lean or Six Sigma).
+ Identifies customer-impacting issues and implement solutions and process improvements to increase customer experiences.
+ Ensures streamlined human processes, workflows, metrics, and system optimization.
+ Helps to define requirements for systems that will facilitate increased efficiencies, automation and/or self-service for various HR processes.
+ May also create test plans, lead testing cycles, and configure systems.
+ Provides segmented professional support to VPs and managers or employees during moments that matters with the ability to emphasize with the customer and apply discretion where needed in interactions with customers.
+ Functional Skills: HR Program Administration, HR Policies, Human Resources Information Systems, Data Analysis, Knowledge Management.
+ Additional Skills: Problem Solving, Detail Oriented, Cross-Functional, Collaboration, Customer Service, Process Improvement, Communication.
**Key Responsibilities in Canada:**
**Benefits Administration**
+ Administer Canadian health and welfare benefit programs, including medical, dental, vision, life insurance, accidental death and dismemberment (AD&D), and other employee benefit offerings.
+ Support employee benefit enrollments, changes, terminations, and beneficiary updates in accordance with plan rules and service level agreements.
+ Support annual benefits enrollment activities and employee communications.
+ Coordinate with third-party benefit providers and brokers to resolve eligibility, claims, and coverage issues.
+ Audit benefit data and transactions to ensure accuracy and compliance.
**Pension Administration**
+ Support the administration of Canadian pension and retirement savings programs, including defined contribution and/or defined benefit plans.
+ Process employee enrollments, terminations, transfers, and retirement-related transactions.
+ Coordinate with pension administrators and vendors to ensure timely and accurate recordkeeping.
+ Respond to employee inquiries regarding pension plan provisions and retirement savings options.
**Disability and Leave Management**
+ Administer short-term disability, long-term disability, workers' compensation, and other income replacement programs.
+ Coordinate leave of absence processes, including medical, parental, maternity, paternity, bereavement, personal, and other statutory or company-sponsored leaves.
+ Maintain regular communication with employees, managers, payroll, and external vendors throughout the leave lifecycle.
+ Monitor leave cases and ensure required documentation is received and maintained.
**Time-Off Administration**
+ Administer vacation, sick leave, personal days, and other paid and unpaid time-off programs.
+ Ensure accurate tracking and reporting of employee leave balances.
+ Support managers and employees with time-off policy interpretation and system-related inquiries.
**Employee Support and Service Delivery**
+ Serve as the escalated point of contact for employee inquiries related to benefits, pensions, disability programs, leaves of absence, and time-off policies.
+ Provide accurate and timely responses through HR service delivery channels while maintaining confidentiality of sensitive employee information.
+ Escalate complex cases as appropriate and collaborate with internal stakeholders to resolve issues.
**Compliance, Reporting, and Continuous Improvement**
+ Ensure compliance with federal and provincial employment standards, pension regulations, privacy legislation, and company policies.
+ Maintain accurate employee records and documentation within HRIS and case management systems.
+ Generate and analyze reports related to benefits, leaves, and pension administration.
+ Identify opportunities to improve processes, enhance employee experience, and increase operational efficiency.
+ Participate in system testing, process documentation, audits, and HR projects as required.
**Key Competencies**
+ Customer Focus
+ Attention to Detail
+ Accountability
+ Collaboration
+ Problem Solving
+ Communication
+ Adaptability
+ Process Improvement
+ Time Management
**Required Qualifications**
+ Must be located in Canada and be fully bilingual in **French** and English (written and verbal).
+ Demonstrated experience administering and supporting employee benefits programs, including health and welfare plans, pension programs, and disability/leave of absence management.
+ Strong ability to work independently, manage competing priorities, and adapt effectively in a dynamic and evolving environment.
**Preferred Qualifications**
+ Experience working with benefits and HR platforms, including Workday, CNESST, and Manulife.
+ Familiarity with Canadian benefits administration processes, regulations, and vendor management.
+ Proven ability to navigate complex employee benefit and leave-related inquiries while delivering a high level of service.
**Salary Range: $64000 - $8000**
**PLEASE NOTE:**
+ We use artificial intelligence (AI) to review resumes of candidates and assess their fit based on the criteria outlined in the job posting. We do not use AI to make any final hiring or interview decisions.
+ This posting reflects a current, genuine vacancy that we are actively recruiting to fill
**PHYSICAL JOB REQUIREMENTS**
+ _The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers._
Medtronic Canada strives through our vision to build a culture of inclusiveness through our commitment to employment equity and diversity. Discrimination is prohibited on any grounds protected under Canadian Human Rights legislation. Employment applications are encouraged from all members of our community. Upon request, candidates with disabilities will be accommodated during the recruitment process.
**SPECIALIST CAREER STREAM:** Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
**DIFFERENTIATING FACTORS**
**Autonomy:** Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.
**Organizational Impact:** Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones.
May have some involvement in cross functional assignments.
**Innovation and Complexity:** Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex.
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
**Communication and Influence:** Communicates primarily and frequently with internal contacts.
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
**Leadership and Talent Management:** May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
**Required Knowledge and Experience:** Requires 2+ years of experience with a high school diploma or equivalent or advanced degree with 0 years of experience.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
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Medical Director - Canada Plasma Operations
Posted 4 days ago
Job Viewed
Job Description
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.
**Position title:** Medical Director, Canada Plasma Operations
**Reports to:** Chief Quality Officer
The **Medical Director, Canada Plasma Operations** , provides strategic medical leadership and oversight for Grifols' plasma collection operations across Canada. The role is accountable for ensuring donor safety, donor eligibility determinations, medical compliance, and the implementation of evidence-based medical practices across all plasma donor centers.
The Medical Director serves as the designated medical authority for plasma collection activities, providing guidance to center physicians, medical staff, operations, quality, regulatory affairs, and senior leadership. The position is responsible for ensuring compliance with applicable Canadian federal and provincial requirements, including the Food and Drugs Act, Food and Drug Regulations, Health Canada Blood Regulations, applicable provincial health legislation, standards from Canadian Blood Services (CBS) where relevant, and international standards including EMA, PPTA IQPP, and corporate requirements.
The Medical Director acts as the primary medical liaison with Health Canada and provincial public health authorities on matters related to donor safety, adverse events, donor eligibility, and medical oversight of plasma collection operations.
This role serves as the senior medical authority for Grifols Canada's plasma collection operations and is responsible for fostering a culture of donor safety, scientific excellence, regulatory compliance, and continuous improvement.
**Primary Responsibilities**
+ **Medical Oversight and Donor Safety**
+ Provide medical leadership and oversight for all Canadian plasma donor centers.
+ Ensure donor safety remains the highest priority in all plasma collection activities.
+ Establish, maintain, and continuously improve medical policies, directives, and procedures related to:
+ Donor eligibility and suitability.
+ Donor assessment and selection.
+ Donor informed consent.
+ Donor counseling and education.
+ Management of donor adverse events and reactions.
+ Donor re-entry and deferral programs.
+ Review and approve medical criteria used for donor acceptance, temporary deferral, permanent deferral, and donor requalification.
+ Provide medical consultation and support for complex donor eligibility determinations.
+ Serve as escalation point for significant donor medical events, safety concerns, and emerging donor risks.
+ Oversee medical investigations
+ **Regulatory Compliance**
+ Ensure medical practices comply with:
+ Health Canada Blood Regulations.
+ Food and Drugs Act and Regulations.
+ Applicable provincial healthcare and privacy legislation.
+ Personal Information Protection and Electronic Documents Act (PIPEDA).
+ Provincial privacy requirements where applicable.
+ PPTA International Quality Plasma Program (IQPP) standards.
+ European Medicines Agency (EMA) requirements applicable to source plasma intended for fractionation.
+ Other applicable international regulatory requirements.
+ Act as medical representative during Health Canada inspections, regulatory meetings, and compliance activities.
+ Support responses to regulatory observations, corrective actions, and commitments involving medical operations.
+ Monitor evolving regulatory and scientific developments affecting donor eligibility, donor safety, infectious disease risks, and plasma collection practices.
+ **Medical Leadership and Governance**
+ Lead the development, implementation, review, and continuous improvement of medical governance programs.
+ Chair or participate in Medical Review Committees, Donor Safety Committees, Plasmavigilance Committees, and other governance forums.
+ Establish medical performance indicators and monitor trends related to donor safety, donor reactions, donor retention, and operational medical performance.
+ Review internal audits, inspections, quality metrics, and medical performance data to identify opportunities for improvement.
+ Provide medical leadership for risk assessments related to donor safety and plasma collection operations.
+ **Physician and Medical Staff Management**
+ Develop and maintain standards for recruitment, qualification, training, credentialing, and ongoing competency assessment of:
+ Center Medical Directors.
+ Contract physicians.
+ Physician substitutes.
+ Medical support personnel.
+ Oversee physician coverage strategies across the Canadian donor center network.
+ Participate in physician recruitment, interviewing, onboarding, performance management, and contract review.
+ Conduct periodic meetings and performance reviews with medical personnel.
+ Ensure consistent application of donor eligibility criteria across all Canadian centers.
+ **Training and Medical Education**
+ Collaborate with Quality, Operations, and Training departments to develop and maintain training programs related to:
+ Donor assessment.
+ Medical screening.
+ Donor safety.
+ Adverse event recognition and management.
+ Emerging medical and epidemiological risks.
+ Provide medical subject matter expertise for development and revision of Standard Operating Procedures.
+ Support certification and recertification programs for medical staff.
+ Promote evidence-based medical decision-making throughout the organization.
+ **Medical Surveillance and Risk Management**
+ Oversee donor safety surveillance programs and medical trend analysis.
+ Review adverse event reports, donor complaints, and donor safety indicators.
+ Lead medical assessments related to:
+ Emerging infectious diseases.
+ Epidemiological threats.
+ Public health alerts.
+ New donor screening requirements.
+ Provide medical recommendations during public health emergencies or disease outbreaks.
+ Collaborate with Quality, Regulatory Affairs, and Operations to implement risk mitigation strategies.
+ **Strategic Leadership**
+ Provide strategic medical input to senior leadership regarding plasma collection operations.
+ Participate in business planning, regulatory strategy, expansion activities, and licensing initiatives.
+ Support acquisitions, integrations, and new center openings from a medical oversight perspective.
+ Contribute to development of long-term donor safety and medical governance strategies.
+ Represent Grifols at industry organizations, professional societies, scientific meetings, and regulatory forums.
+ **Research and Scientific Affairs**
+ Monitor scientific literature relevant to plasmapheresis, donor safety, and transfusion medicine.
+ Support development and execution of clinical and observational research initiatives when applicable.
+ Collaborate with external experts, academic institutions, and industry groups.
+ Contribute to scientific publications, presentations, and regulatory submissions as appropriate.
**Education** :
+ Doctor of Medicine (MD) degree from an accredited medical school.
+ Active unrestricted license to practice medicine in Canada, or eligibility to obtain licensure in any Canadian province.
+ Certification by the Royal College of Physicians and Surgeons of Canada, College of Family Physicians of Canada, or equivalent recognized medical specialty certification preferred.
**Experience** :
+ Minimum 10 years of progressive medical leadership experience.
+ Minimum 5 years of experience in blood, plasma, transfusion medicine, hematology, donor medicine, public health, pharmaceutical, biologics, or regulated healthcare environments.
+ Experience interacting with Health Canada and healthcare regulators preferred.
+ Experience supporting inspections, audits, and regulatory submissions preferred.
+ Experience leading geographically dispersed medical teams preferred.
**Knowledge | Skills | Abilities**
+ Health Canada Blood Regulations.
+ Food and Drugs Act and Food and Drug Regulations.
+ Canadian blood establishment licensing requirements.
+ Donor eligibility and donor safety practices.
+ Transfusion medicine and plasmapheresis operations.
+ Epidemiology and infectious disease risk management.
+ Privacy legislation including PIPEDA and provincial privacy requirements.
+ PPTA IQPP standards.
+ EMA requirements for plasma used in fractionation.
+ Strong leadership and change management capabilities.
+ Excellent communication and stakeholder management skills.
+ Strategic thinking and problem-solving ability.
+ Ability to interact effectively with regulators, healthcare professionals, public health authorities, and senior executives.
+ Strong analytical and risk assessment skills.
+ Ability to travel domestically and internationally as required.
**_Occupational Demands_** _:_
_Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues._
**Canada Careers Privacy Notice ( de confidentialité de Canada - Careers**
**Location: NORTH AMERICA : Canada : ON-Toronto:CAHOME - Home Address Canada**
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:** GENERAL MANAGEMENT
Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.
**Position title:** Medical Director, Canada Plasma Operations
**Reports to:** Chief Quality Officer
The **Medical Director, Canada Plasma Operations** , provides strategic medical leadership and oversight for Grifols' plasma collection operations across Canada. The role is accountable for ensuring donor safety, donor eligibility determinations, medical compliance, and the implementation of evidence-based medical practices across all plasma donor centers.
The Medical Director serves as the designated medical authority for plasma collection activities, providing guidance to center physicians, medical staff, operations, quality, regulatory affairs, and senior leadership. The position is responsible for ensuring compliance with applicable Canadian federal and provincial requirements, including the Food and Drugs Act, Food and Drug Regulations, Health Canada Blood Regulations, applicable provincial health legislation, standards from Canadian Blood Services (CBS) where relevant, and international standards including EMA, PPTA IQPP, and corporate requirements.
The Medical Director acts as the primary medical liaison with Health Canada and provincial public health authorities on matters related to donor safety, adverse events, donor eligibility, and medical oversight of plasma collection operations.
This role serves as the senior medical authority for Grifols Canada's plasma collection operations and is responsible for fostering a culture of donor safety, scientific excellence, regulatory compliance, and continuous improvement.
**Primary Responsibilities**
+ **Medical Oversight and Donor Safety**
+ Provide medical leadership and oversight for all Canadian plasma donor centers.
+ Ensure donor safety remains the highest priority in all plasma collection activities.
+ Establish, maintain, and continuously improve medical policies, directives, and procedures related to:
+ Donor eligibility and suitability.
+ Donor assessment and selection.
+ Donor informed consent.
+ Donor counseling and education.
+ Management of donor adverse events and reactions.
+ Donor re-entry and deferral programs.
+ Review and approve medical criteria used for donor acceptance, temporary deferral, permanent deferral, and donor requalification.
+ Provide medical consultation and support for complex donor eligibility determinations.
+ Serve as escalation point for significant donor medical events, safety concerns, and emerging donor risks.
+ Oversee medical investigations
+ **Regulatory Compliance**
+ Ensure medical practices comply with:
+ Health Canada Blood Regulations.
+ Food and Drugs Act and Regulations.
+ Applicable provincial healthcare and privacy legislation.
+ Personal Information Protection and Electronic Documents Act (PIPEDA).
+ Provincial privacy requirements where applicable.
+ PPTA International Quality Plasma Program (IQPP) standards.
+ European Medicines Agency (EMA) requirements applicable to source plasma intended for fractionation.
+ Other applicable international regulatory requirements.
+ Act as medical representative during Health Canada inspections, regulatory meetings, and compliance activities.
+ Support responses to regulatory observations, corrective actions, and commitments involving medical operations.
+ Monitor evolving regulatory and scientific developments affecting donor eligibility, donor safety, infectious disease risks, and plasma collection practices.
+ **Medical Leadership and Governance**
+ Lead the development, implementation, review, and continuous improvement of medical governance programs.
+ Chair or participate in Medical Review Committees, Donor Safety Committees, Plasmavigilance Committees, and other governance forums.
+ Establish medical performance indicators and monitor trends related to donor safety, donor reactions, donor retention, and operational medical performance.
+ Review internal audits, inspections, quality metrics, and medical performance data to identify opportunities for improvement.
+ Provide medical leadership for risk assessments related to donor safety and plasma collection operations.
+ **Physician and Medical Staff Management**
+ Develop and maintain standards for recruitment, qualification, training, credentialing, and ongoing competency assessment of:
+ Center Medical Directors.
+ Contract physicians.
+ Physician substitutes.
+ Medical support personnel.
+ Oversee physician coverage strategies across the Canadian donor center network.
+ Participate in physician recruitment, interviewing, onboarding, performance management, and contract review.
+ Conduct periodic meetings and performance reviews with medical personnel.
+ Ensure consistent application of donor eligibility criteria across all Canadian centers.
+ **Training and Medical Education**
+ Collaborate with Quality, Operations, and Training departments to develop and maintain training programs related to:
+ Donor assessment.
+ Medical screening.
+ Donor safety.
+ Adverse event recognition and management.
+ Emerging medical and epidemiological risks.
+ Provide medical subject matter expertise for development and revision of Standard Operating Procedures.
+ Support certification and recertification programs for medical staff.
+ Promote evidence-based medical decision-making throughout the organization.
+ **Medical Surveillance and Risk Management**
+ Oversee donor safety surveillance programs and medical trend analysis.
+ Review adverse event reports, donor complaints, and donor safety indicators.
+ Lead medical assessments related to:
+ Emerging infectious diseases.
+ Epidemiological threats.
+ Public health alerts.
+ New donor screening requirements.
+ Provide medical recommendations during public health emergencies or disease outbreaks.
+ Collaborate with Quality, Regulatory Affairs, and Operations to implement risk mitigation strategies.
+ **Strategic Leadership**
+ Provide strategic medical input to senior leadership regarding plasma collection operations.
+ Participate in business planning, regulatory strategy, expansion activities, and licensing initiatives.
+ Support acquisitions, integrations, and new center openings from a medical oversight perspective.
+ Contribute to development of long-term donor safety and medical governance strategies.
+ Represent Grifols at industry organizations, professional societies, scientific meetings, and regulatory forums.
+ **Research and Scientific Affairs**
+ Monitor scientific literature relevant to plasmapheresis, donor safety, and transfusion medicine.
+ Support development and execution of clinical and observational research initiatives when applicable.
+ Collaborate with external experts, academic institutions, and industry groups.
+ Contribute to scientific publications, presentations, and regulatory submissions as appropriate.
**Education** :
+ Doctor of Medicine (MD) degree from an accredited medical school.
+ Active unrestricted license to practice medicine in Canada, or eligibility to obtain licensure in any Canadian province.
+ Certification by the Royal College of Physicians and Surgeons of Canada, College of Family Physicians of Canada, or equivalent recognized medical specialty certification preferred.
**Experience** :
+ Minimum 10 years of progressive medical leadership experience.
+ Minimum 5 years of experience in blood, plasma, transfusion medicine, hematology, donor medicine, public health, pharmaceutical, biologics, or regulated healthcare environments.
+ Experience interacting with Health Canada and healthcare regulators preferred.
+ Experience supporting inspections, audits, and regulatory submissions preferred.
+ Experience leading geographically dispersed medical teams preferred.
**Knowledge | Skills | Abilities**
+ Health Canada Blood Regulations.
+ Food and Drugs Act and Food and Drug Regulations.
+ Canadian blood establishment licensing requirements.
+ Donor eligibility and donor safety practices.
+ Transfusion medicine and plasmapheresis operations.
+ Epidemiology and infectious disease risk management.
+ Privacy legislation including PIPEDA and provincial privacy requirements.
+ PPTA IQPP standards.
+ EMA requirements for plasma used in fractionation.
+ Strong leadership and change management capabilities.
+ Excellent communication and stakeholder management skills.
+ Strategic thinking and problem-solving ability.
+ Ability to interact effectively with regulators, healthcare professionals, public health authorities, and senior executives.
+ Strong analytical and risk assessment skills.
+ Ability to travel domestically and internationally as required.
**_Occupational Demands_** _:_
_Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues._
**Canada Careers Privacy Notice ( de confidentialité de Canada - Careers**
**Location: NORTH AMERICA : Canada : ON-Toronto:CAHOME - Home Address Canada**
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:** GENERAL MANAGEMENT
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Apply Now
1
Solutions Consultant 2 - Federal Government and Shared Services
Ottawa
Palo Alto Networks
Posted 4 days ago
Job Viewed
Job Description
**Our Mission**
At Palo Alto Networks®, we're united by a shared mission-to protect our digital way of life. We thrive at the intersection of innovation and impact, solving real-world problems with cutting-edge technology and bold thinking. Here, everyone has a voice, and every idea counts. If you're ready to do the most meaningful work of your career alongside people who are just as passionate as you are, you're in the right place.
**Who We Are**
In order to be the cybersecurity partner of choice, we must trailblaze the path and shape the future of our industry. This is something our employees work at each day and is defined by our values: Disruption, Collaboration, Execution, Integrity, and Inclusion. We weave AI into the fabric of everything we do and use it to augment the impact every individual can have. If you are passionate about solving real-world problems and ideating beside the best and the brightest, we invite you to join us!
This role is remote, but distance is no barrier to impact. Our hybrid teams collaborate across geographies to solve big problems, stay close to our customers, and grow together. You will be part of a culture that values trust, accountability, and shared success where your work truly matters.
**Job Summary**
Job Description
**Your Career**
The Solutions Consultant is the evolution of the traditional Sales Engineering role, aligning how we best serve our customers in understanding their environment, providing solution guidance and ensuring value realization in their investment with Palo Alto Networks. As a Solutions Consultant you provide technical leadership and expertise and guidance in your customer's security transformation journey. You will play a key role in defining technical solutions that secure a customer's key business imperatives and ensuring value realization of their investment with Palo Alto Networks. You evangelize our industry leadership in on-prem, cloud, and security operations services that establish PANW as your customer's cybersecurity partner of choice.
**Your Impact**
+ Curiosity is core to the Solutions Consultant role, and you see complex problems as opportunities to learn and deliver innovative solutions! You define your impact by:
+ Meeting and exceeding sales quotas by building and implementing strategic, technical account plans that target cross-platform solutions.
+ Understands Key customer business requirements and has the ability to position, demonstrate and create high level designs across the entire PANW portfolio solutions creating business value for customers.
+ Ability to drive customer adoption of Palo Alto Networks Platform. Building customer relationships by helping customers achieve increased productivity, operational efficiency, security efficacy, and greater flexibility to innovate.
+ Conducting discovery to understand and articulate the key technical, operational, and commercial imperatives of your prospects and customers
+ Working closely with Professional Services, Customer Success and Specialist teams to ensure overall customer implementation and adoption of solutions.
+ Demonstrating strong communication skills, influencing through effective presentations and customer-specific demos, and conducts technical engagements and workshops that are clear and impactful, simplifying complex ideas for various audiences
+ Leading successful technical validation efforts based on best practices to ensure technical win in assigned opportunities.
+ Demonstrates Cross functional leadership driving collaboration and orchestrating supporting resources (Specialists, Channel Resources, Customer Support) to ensure a one-team approach that demonstrates a cohesive strategy.
+ Promoting end-to-end solutions that include PANW and/or partner professional services to ensure customers realize business value sooner
+ Understanding the competitive landscape and effectively differentiating PANW's leadership in the cybersecurity space
+ Continuously investing in yourself to develop technical and professional skills that drive your ever-increasing contributions to success of our customers while actively participating within the Solutions Consultant community and at industry events
+ Identifying technical stakeholders and cultivating relationships with key personas to build and drive a security architecture transformation roadmap
**Qualifications**
**Your Experience**
+ 6+ years experience in pre-sales/sales engineering
+ Skilled in at least one of the following Networking, Network Security, Cybersecurity, Private/Public Cloud Security, SOC/Endpoint or SASE.
+ Experience in delivering cybersecurity solutions that solve technical challenges and influence new business initiatives is preferred
+ Influencing and gaining buy-in from key stakeholders, either in a customer-facing or internal role; prior experience in a pre-sales role is ideal
+ Creating and delivering technical presentations, workshops, or technical validation engagements
+ Experience in selling, designing, implementing, or managing one or more of the following solutions: Network Security, SASE, SaaS, CNAPP and/or SOC Transformation Technologies
+ Partnering with Customer Support functions to ensure successful implementation and adoption of sold solutions
+ Experience in complex sales involving long sales processes with multiple buying centers and multi-product solutions are preferred
+ This is a field sales position where travel requirements may be required to support in person customer meetings, please discuss with the recruiter on the specifics for this position.
+ Proficient in English
**Compensation Disclosure**
The compensation offered for this position will depend on qualifications, experience, and work location. For candidates who receive an offer at the posted level, the starting base salary (for non-sales roles) or base salary + commission target (for sales/com-missioned roles) is expected to be the annual range listed below. The offered compensation may also include restricted stock units and a bonus. A description of our employee benefits may be found here ( .
$204,800.00 - $281,600.00/yr
**Our Commitment**
We're trailblazers that dream big, take risks, and challenge cybersecurity's status quo. It's simple: we can't accomplish our mission without diverse teams innovating, together.
We are committed to providing reasonable accommodations for all qualified individuals with a disability. If you require assistance or accommodation due to a disability or special need, please contact us at .
Palo Alto Networks is an equal opportunity employer. We celebrate diversity in our workplace, and all qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or other legally protected characteristics.
All your information will be kept confidential according to EEO guidelines.
Is role eligible for Immigration Sponsorship? No. Please note that we will not sponsor applicants for work visas for this position.
At Palo Alto Networks®, we're united by a shared mission-to protect our digital way of life. We thrive at the intersection of innovation and impact, solving real-world problems with cutting-edge technology and bold thinking. Here, everyone has a voice, and every idea counts. If you're ready to do the most meaningful work of your career alongside people who are just as passionate as you are, you're in the right place.
**Who We Are**
In order to be the cybersecurity partner of choice, we must trailblaze the path and shape the future of our industry. This is something our employees work at each day and is defined by our values: Disruption, Collaboration, Execution, Integrity, and Inclusion. We weave AI into the fabric of everything we do and use it to augment the impact every individual can have. If you are passionate about solving real-world problems and ideating beside the best and the brightest, we invite you to join us!
This role is remote, but distance is no barrier to impact. Our hybrid teams collaborate across geographies to solve big problems, stay close to our customers, and grow together. You will be part of a culture that values trust, accountability, and shared success where your work truly matters.
**Job Summary**
Job Description
**Your Career**
The Solutions Consultant is the evolution of the traditional Sales Engineering role, aligning how we best serve our customers in understanding their environment, providing solution guidance and ensuring value realization in their investment with Palo Alto Networks. As a Solutions Consultant you provide technical leadership and expertise and guidance in your customer's security transformation journey. You will play a key role in defining technical solutions that secure a customer's key business imperatives and ensuring value realization of their investment with Palo Alto Networks. You evangelize our industry leadership in on-prem, cloud, and security operations services that establish PANW as your customer's cybersecurity partner of choice.
**Your Impact**
+ Curiosity is core to the Solutions Consultant role, and you see complex problems as opportunities to learn and deliver innovative solutions! You define your impact by:
+ Meeting and exceeding sales quotas by building and implementing strategic, technical account plans that target cross-platform solutions.
+ Understands Key customer business requirements and has the ability to position, demonstrate and create high level designs across the entire PANW portfolio solutions creating business value for customers.
+ Ability to drive customer adoption of Palo Alto Networks Platform. Building customer relationships by helping customers achieve increased productivity, operational efficiency, security efficacy, and greater flexibility to innovate.
+ Conducting discovery to understand and articulate the key technical, operational, and commercial imperatives of your prospects and customers
+ Working closely with Professional Services, Customer Success and Specialist teams to ensure overall customer implementation and adoption of solutions.
+ Demonstrating strong communication skills, influencing through effective presentations and customer-specific demos, and conducts technical engagements and workshops that are clear and impactful, simplifying complex ideas for various audiences
+ Leading successful technical validation efforts based on best practices to ensure technical win in assigned opportunities.
+ Demonstrates Cross functional leadership driving collaboration and orchestrating supporting resources (Specialists, Channel Resources, Customer Support) to ensure a one-team approach that demonstrates a cohesive strategy.
+ Promoting end-to-end solutions that include PANW and/or partner professional services to ensure customers realize business value sooner
+ Understanding the competitive landscape and effectively differentiating PANW's leadership in the cybersecurity space
+ Continuously investing in yourself to develop technical and professional skills that drive your ever-increasing contributions to success of our customers while actively participating within the Solutions Consultant community and at industry events
+ Identifying technical stakeholders and cultivating relationships with key personas to build and drive a security architecture transformation roadmap
**Qualifications**
**Your Experience**
+ 6+ years experience in pre-sales/sales engineering
+ Skilled in at least one of the following Networking, Network Security, Cybersecurity, Private/Public Cloud Security, SOC/Endpoint or SASE.
+ Experience in delivering cybersecurity solutions that solve technical challenges and influence new business initiatives is preferred
+ Influencing and gaining buy-in from key stakeholders, either in a customer-facing or internal role; prior experience in a pre-sales role is ideal
+ Creating and delivering technical presentations, workshops, or technical validation engagements
+ Experience in selling, designing, implementing, or managing one or more of the following solutions: Network Security, SASE, SaaS, CNAPP and/or SOC Transformation Technologies
+ Partnering with Customer Support functions to ensure successful implementation and adoption of sold solutions
+ Experience in complex sales involving long sales processes with multiple buying centers and multi-product solutions are preferred
+ This is a field sales position where travel requirements may be required to support in person customer meetings, please discuss with the recruiter on the specifics for this position.
+ Proficient in English
**Compensation Disclosure**
The compensation offered for this position will depend on qualifications, experience, and work location. For candidates who receive an offer at the posted level, the starting base salary (for non-sales roles) or base salary + commission target (for sales/com-missioned roles) is expected to be the annual range listed below. The offered compensation may also include restricted stock units and a bonus. A description of our employee benefits may be found here ( .
$204,800.00 - $281,600.00/yr
**Our Commitment**
We're trailblazers that dream big, take risks, and challenge cybersecurity's status quo. It's simple: we can't accomplish our mission without diverse teams innovating, together.
We are committed to providing reasonable accommodations for all qualified individuals with a disability. If you require assistance or accommodation due to a disability or special need, please contact us at .
Palo Alto Networks is an equal opportunity employer. We celebrate diversity in our workplace, and all qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or other legally protected characteristics.
All your information will be kept confidential according to EEO guidelines.
Is role eligible for Immigration Sponsorship? No. Please note that we will not sponsor applicants for work visas for this position.
Is this job a match or a miss?
Apply Now
2
Vice President, Plasma Operations Canada
Posted 1 day ago
Job Viewed
Job Description
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.
**Summary:**
Position provides overall strategic direction and guidance to the operational activities of the Canada plasma donor center organization with the objective of optimizing plasma procurement and profitability while maintaining the highest degree of compliance and quality. Direct and full responsibility over Plasma operations in Canada developing and creating strategies and policies aligned with the organizational goals in the areas of donor recruitment, facilities, production management, new donor centers opening, inventory management and resource utilization. Approves budgets, plans and goals for the control of the planned production, budgeted spending, labor efficiency, material efficiency, engineering effectiveness of capital spending, order entry, quality and human capital utilization (e.g. staffing and professional development). Responsible for the development of the annual and long-range operating plan, budget (operating and capital). Directs and oversees operational activities and projects to ensure business goals are achieved and results are in line with the stated objectives. Resides as a member of the Canada Management Committee Team, whichs includes defining Operations Strategy, key business decisions, monitor performance and share with the rest of the executive team. Also, establish leadership and culture and ensure cross-functional alignment and Risk management.
**Primary responsibilities for role (level-specific responsibilities should be included in the chart below):**
● Assists in the development of the Canada plasma operations strategic plan to advance the Company's mission and objectives and to support continuous organizational growth and profitability.
● Implements programs to ensure attainment of business plans for growth and profit. Provides direction and structure for operating units.
● Oversees team of senior leaders and the general manager and field levels and makes recommendations for all strategic decisions regarding plasma procurement and generation strategies, headcount, expense management, financial forecasting and overall divisional direction.
● Approves divisional operating procedures, policies, and standards in compliance with FDA, EMA, and other regulatory standards.
● Develops and maintains the headcount, capital forecasts, and operational expense budgets for plasma production
● The role will work closely with Quality team to ensure Grifols quality standards are implemented and followed.
● Directs, appraises and sets appropriate measurement targets for the performance of all operational functions of the donor centers, including quality and production goals.
● Responsible for the proper integration of newly acquired donor centers as well as meeting volume and quality targets.
● Responsible for the opening and ramp up of the new Donor Centers volume and assuring Grifols quality standards are implemented.
● Reviews and evaluations operational performance on a continuing bases, establishes appropriate measures of performance, and creates contingency plans in accordance with prevailing business conditions.
● Implements improved processes and management methods to generate higher return on investment (ROI) and workflow optimization
● Selects and maintains qualified personnel in accordance with workforce planning needs and identifies training opportunities for the development of subordinates.
● The role will report to the Managing Director Canada.
● Partnership with CBS from a plasma perspective and also can be part of the CBS-Grifols collaboration groups.
● Maintains key relationships with industry and trade associations, representatives of government, public service organizations, and the community to properly represent Grifols' interests
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
**Skills/Qualifications/Education:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Bachelors degree in Life Sciences, Business, Engineering or equivalent required. MBA preferred.
Minimum of 15 years management experience in the plasma collection industry or the bio-tech/pharma manufacturing industry, including experience leading a large organization at the executive level.
Strong knowledge of plasmapherisis donor center management and operations to directly manage the disciplines of donor procurement and quality assurance in a bio-tech/plasma industry. Technical expertise and strong operational and project management skills. Effective team building and leadership skills. Excellent oral and written communication skills. Ability to effectively collaborate and work with all levels within a global, matrix-driven organization.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations, frequently travels within the Canada, occasional international travel. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. The VP Canada Plasma Operations must reside in Toronto, Canada.
**Canada Careers Privacy Notice ( de confidentialité de Canada - Careers**
**Location: NORTH AMERICA : Canada : ON-Toronto | NORTH AMERICA : Canada : AB-Alberta | NORTH AMERICA : Canada : AB-Edmonton | NORTH AMERICA : Canada : BC-British Columbia | NORTH AMERICA : Canada : Home Office | NORTH AMERICA : Canada : MB-Winnipeg | NORTH AMERICA : Canada : Mississauga | NORTH AMERICA : Canada : Montreal | NORTH AMERICA : Canada : ON-Ontario | NORTH AMERICA : Canada : QC-Quebec:CAHOME - Home Address Canada**
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:** GENERAL MANAGEMENT
Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.
**Summary:**
Position provides overall strategic direction and guidance to the operational activities of the Canada plasma donor center organization with the objective of optimizing plasma procurement and profitability while maintaining the highest degree of compliance and quality. Direct and full responsibility over Plasma operations in Canada developing and creating strategies and policies aligned with the organizational goals in the areas of donor recruitment, facilities, production management, new donor centers opening, inventory management and resource utilization. Approves budgets, plans and goals for the control of the planned production, budgeted spending, labor efficiency, material efficiency, engineering effectiveness of capital spending, order entry, quality and human capital utilization (e.g. staffing and professional development). Responsible for the development of the annual and long-range operating plan, budget (operating and capital). Directs and oversees operational activities and projects to ensure business goals are achieved and results are in line with the stated objectives. Resides as a member of the Canada Management Committee Team, whichs includes defining Operations Strategy, key business decisions, monitor performance and share with the rest of the executive team. Also, establish leadership and culture and ensure cross-functional alignment and Risk management.
**Primary responsibilities for role (level-specific responsibilities should be included in the chart below):**
● Assists in the development of the Canada plasma operations strategic plan to advance the Company's mission and objectives and to support continuous organizational growth and profitability.
● Implements programs to ensure attainment of business plans for growth and profit. Provides direction and structure for operating units.
● Oversees team of senior leaders and the general manager and field levels and makes recommendations for all strategic decisions regarding plasma procurement and generation strategies, headcount, expense management, financial forecasting and overall divisional direction.
● Approves divisional operating procedures, policies, and standards in compliance with FDA, EMA, and other regulatory standards.
● Develops and maintains the headcount, capital forecasts, and operational expense budgets for plasma production
● The role will work closely with Quality team to ensure Grifols quality standards are implemented and followed.
● Directs, appraises and sets appropriate measurement targets for the performance of all operational functions of the donor centers, including quality and production goals.
● Responsible for the proper integration of newly acquired donor centers as well as meeting volume and quality targets.
● Responsible for the opening and ramp up of the new Donor Centers volume and assuring Grifols quality standards are implemented.
● Reviews and evaluations operational performance on a continuing bases, establishes appropriate measures of performance, and creates contingency plans in accordance with prevailing business conditions.
● Implements improved processes and management methods to generate higher return on investment (ROI) and workflow optimization
● Selects and maintains qualified personnel in accordance with workforce planning needs and identifies training opportunities for the development of subordinates.
● The role will report to the Managing Director Canada.
● Partnership with CBS from a plasma perspective and also can be part of the CBS-Grifols collaboration groups.
● Maintains key relationships with industry and trade associations, representatives of government, public service organizations, and the community to properly represent Grifols' interests
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
**Skills/Qualifications/Education:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Bachelors degree in Life Sciences, Business, Engineering or equivalent required. MBA preferred.
Minimum of 15 years management experience in the plasma collection industry or the bio-tech/pharma manufacturing industry, including experience leading a large organization at the executive level.
Strong knowledge of plasmapherisis donor center management and operations to directly manage the disciplines of donor procurement and quality assurance in a bio-tech/plasma industry. Technical expertise and strong operational and project management skills. Effective team building and leadership skills. Excellent oral and written communication skills. Ability to effectively collaborate and work with all levels within a global, matrix-driven organization.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations, frequently travels within the Canada, occasional international travel. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. The VP Canada Plasma Operations must reside in Toronto, Canada.
**Canada Careers Privacy Notice ( de confidentialité de Canada - Careers**
**Location: NORTH AMERICA : Canada : ON-Toronto | NORTH AMERICA : Canada : AB-Alberta | NORTH AMERICA : Canada : AB-Edmonton | NORTH AMERICA : Canada : BC-British Columbia | NORTH AMERICA : Canada : Home Office | NORTH AMERICA : Canada : MB-Winnipeg | NORTH AMERICA : Canada : Mississauga | NORTH AMERICA : Canada : Montreal | NORTH AMERICA : Canada : ON-Ontario | NORTH AMERICA : Canada : QC-Quebec:CAHOME - Home Address Canada**
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:** GENERAL MANAGEMENT
Is this job a match or a miss?
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3
Spécialiste, Assurance Qualité - Quality Assurance Specialist
Posted 4 days ago
Job Viewed
Job Description
Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Titre du poste : Spécialiste, Assurance Qualité
Relève de : Superviseur, Assurance Qualité
**Principales fonctions et responsabilités :**
+ Effectuer les fonctions quotidiennes suivantes, mais sans s'y limiter :
+ Examen des déviations, investigations et CAPA ;
+ Examen de la procédure, des enregistrements de lots (BPR), des journaux de bord, des rapports et toute documentation générée par le département de fabrication et d'autres départements ;
+ Révision/approbation des activités et des documents liés à la qualité et aux opérations (journaux de bord, état des salles/équipements, dossiers de formation, enquêtes, etc.) en relation avec les demandes de changement, les déviations, les investigations et les CAPA, selon les besoins ;
+ Examen / approbation des systèmes qualité tels que la gestion des écarts, la quarantaine, la libération des lots, SAP, le module qualité SAP, la documentation, ainsi que l'apport d'une contribution qualité pour les projets de validation ;
+ Coordonner l'examen périodique des procédures et autres documents qualité ;
+ Initier des déviations, des investigations, des CAPA et des demandes de changement liées aux documents/processus BPF, selon les besoins ;
+ Assurer l'intégrité et la traçabilité de toutes les données générées et rapportées ;
+ Générer de nouvelles procédures et réviser les procédures existantes, si nécessaire ;
+ Recueillir des données sur les déviations, les investigations, les CAPA et les demandes de changement pour les examens annuels des produits ;
+ Fournir un soutien aux autres départements tels que la production, le contrôle qualité, la validation et l'ingénierie ;
+ Développer et signaler des mesures de qualité pour les déviations et d'autres systèmes, tel qu'assignées ;.
+ Assumer des responsabilités supplémentaires dans le cadre du programme de système qualité, telles qu'enseignées et assignées.
**Exigences requises :**
+ Baccalauréat en sciences minimum (de préférence en microbiologie, chimie, biologie) ;
+ Au moins 2 à 3 ans d'expérience en assurance qualité au sein de l'industrie manufacturière biopharmaceutique ou pharmaceutique ;
+ Expertise de niveau Spécialiste avec une connaissance avancée des systèmes qualité (contrôle des changements, déviations, investigations, analyse des causes fondamentales, CAPA et évaluations des risques) ;
+ Faire preuve de jugement, de compétence technique et de connaissances essentielles au rôle ;
+ Bonnes compétences informatiques avec MS Office et Adobe Acrobat ;
+ Solides compétences organisationnelles, y compris le souci du détail et la capacité à respecter les délais ;
+ Capable d'appliquer, de suivre et de maintenir rigoureusement les règles, les exigences réglementaires, les procédures et les processus ;
+ Capable de travailler de manière autonome et en équipe ;
+ Capable d'effectuer plusieurs tâches à la fois tout en collaborant pour atteindre et dépasser les objectifs ;
+ Diriger les initiatives d'amélioration des pratiques, des processus et de la qualité de l'entreprise ;
+ Soutenir et collaborer activement avec ses collègues ;
+ Faciliter la collaboration interfonctionnelle et gérer les projets assignés ;
+ Bonnes compétences en communication orale et écrite et bonne aptitudes relationnelles ;
+ Bilingue en français et en anglais (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA).
Position title: Quality Assurance Specialist
Reports to: Quality Assurance Supervisor
**Key Duties and Responsibilities**
+ Perform the following day-to-day functions, but not limited to:
+ Review of Deviations, Investigations, and CAPA
+ Review of procedure, Batch Productions Records (BPRs), logbooks, reports, and any documentation generated by Manufacturing and other departments
+ Review/Approval of Quality and Operations Activities and Documents (logbooks, room / equipment status, training records, investigations, etc.) in relation to Change Requests, and Deviations, Investigations, and CAPA, as needed
+ Review/approval of quality systems such as Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, as well as provide Quality input for Validation projects.
+ Coordinate periodic review of procedures and other quality documents
+ Initiate Deviations, Investigations, CAPA, Change Requests related to GMP documents / processes, as required
+ Ensure the integrity and traceability of all data generated and reported
+ Generate new procedures and revise existing procedures, as required
+ Gather Deviations, Investigations, CAPA and Change Request data for Annual Product Reviews
+ Provide cross departmental support to production, QC, validation and engineering
+ Develop and Report Quality Metrics for Deviations and other systems, as assigned
+ Perform additional Quality System program responsibilities as trained on and assigned
**Qualifications:**
+ Education: At minimum, must have a B. Science, (Preferred: Microbiology, Chemistry, Biology)
+ At least 2 - 3 years' experience in QA within the Biopharmaceutical or Pharmaceutical manufacturing Industry
+ Specialist level expertise with advanced knowledge of quality systems (change control, deviations, investigations, root cause analysis, CAPA and risk assessments)
+ Demonstrates judgment, technical competence and knowledge critical for role
+ Good computer skills with MS Office and Adobe Acrobat
+ Strong organizational skills, including attention to detail and ability to meet deadlines
+ Able to rigorously apply, follow and maintain rules, regulatory requirements, procedures and processes
+ Must be able to work independently and as part of a team
+ Able to multi-task while collaborating to achieve and exceed goals
+ Leads improvement initiatives for organization's practices, processes and quality
+ Supports colleagues and actively engages with colleagues
+ Facilitates cross-functional collaboration and manages assigned projects
+ Good oral and written communication skills and good interpersonal skills
+ Bilingual in both French and English (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA).
Politique de confidentialité de Canada - Careers
Canada Careers Privacy Notice ( NORTH AMERICA : Canada : Montreal:CAQUEBEC - Quebec**
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:** TECHNICAL
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Titre du poste : Spécialiste, Assurance Qualité
Relève de : Superviseur, Assurance Qualité
**Principales fonctions et responsabilités :**
+ Effectuer les fonctions quotidiennes suivantes, mais sans s'y limiter :
+ Examen des déviations, investigations et CAPA ;
+ Examen de la procédure, des enregistrements de lots (BPR), des journaux de bord, des rapports et toute documentation générée par le département de fabrication et d'autres départements ;
+ Révision/approbation des activités et des documents liés à la qualité et aux opérations (journaux de bord, état des salles/équipements, dossiers de formation, enquêtes, etc.) en relation avec les demandes de changement, les déviations, les investigations et les CAPA, selon les besoins ;
+ Examen / approbation des systèmes qualité tels que la gestion des écarts, la quarantaine, la libération des lots, SAP, le module qualité SAP, la documentation, ainsi que l'apport d'une contribution qualité pour les projets de validation ;
+ Coordonner l'examen périodique des procédures et autres documents qualité ;
+ Initier des déviations, des investigations, des CAPA et des demandes de changement liées aux documents/processus BPF, selon les besoins ;
+ Assurer l'intégrité et la traçabilité de toutes les données générées et rapportées ;
+ Générer de nouvelles procédures et réviser les procédures existantes, si nécessaire ;
+ Recueillir des données sur les déviations, les investigations, les CAPA et les demandes de changement pour les examens annuels des produits ;
+ Fournir un soutien aux autres départements tels que la production, le contrôle qualité, la validation et l'ingénierie ;
+ Développer et signaler des mesures de qualité pour les déviations et d'autres systèmes, tel qu'assignées ;.
+ Assumer des responsabilités supplémentaires dans le cadre du programme de système qualité, telles qu'enseignées et assignées.
**Exigences requises :**
+ Baccalauréat en sciences minimum (de préférence en microbiologie, chimie, biologie) ;
+ Au moins 2 à 3 ans d'expérience en assurance qualité au sein de l'industrie manufacturière biopharmaceutique ou pharmaceutique ;
+ Expertise de niveau Spécialiste avec une connaissance avancée des systèmes qualité (contrôle des changements, déviations, investigations, analyse des causes fondamentales, CAPA et évaluations des risques) ;
+ Faire preuve de jugement, de compétence technique et de connaissances essentielles au rôle ;
+ Bonnes compétences informatiques avec MS Office et Adobe Acrobat ;
+ Solides compétences organisationnelles, y compris le souci du détail et la capacité à respecter les délais ;
+ Capable d'appliquer, de suivre et de maintenir rigoureusement les règles, les exigences réglementaires, les procédures et les processus ;
+ Capable de travailler de manière autonome et en équipe ;
+ Capable d'effectuer plusieurs tâches à la fois tout en collaborant pour atteindre et dépasser les objectifs ;
+ Diriger les initiatives d'amélioration des pratiques, des processus et de la qualité de l'entreprise ;
+ Soutenir et collaborer activement avec ses collègues ;
+ Faciliter la collaboration interfonctionnelle et gérer les projets assignés ;
+ Bonnes compétences en communication orale et écrite et bonne aptitudes relationnelles ;
+ Bilingue en français et en anglais (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA).
Position title: Quality Assurance Specialist
Reports to: Quality Assurance Supervisor
**Key Duties and Responsibilities**
+ Perform the following day-to-day functions, but not limited to:
+ Review of Deviations, Investigations, and CAPA
+ Review of procedure, Batch Productions Records (BPRs), logbooks, reports, and any documentation generated by Manufacturing and other departments
+ Review/Approval of Quality and Operations Activities and Documents (logbooks, room / equipment status, training records, investigations, etc.) in relation to Change Requests, and Deviations, Investigations, and CAPA, as needed
+ Review/approval of quality systems such as Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, as well as provide Quality input for Validation projects.
+ Coordinate periodic review of procedures and other quality documents
+ Initiate Deviations, Investigations, CAPA, Change Requests related to GMP documents / processes, as required
+ Ensure the integrity and traceability of all data generated and reported
+ Generate new procedures and revise existing procedures, as required
+ Gather Deviations, Investigations, CAPA and Change Request data for Annual Product Reviews
+ Provide cross departmental support to production, QC, validation and engineering
+ Develop and Report Quality Metrics for Deviations and other systems, as assigned
+ Perform additional Quality System program responsibilities as trained on and assigned
**Qualifications:**
+ Education: At minimum, must have a B. Science, (Preferred: Microbiology, Chemistry, Biology)
+ At least 2 - 3 years' experience in QA within the Biopharmaceutical or Pharmaceutical manufacturing Industry
+ Specialist level expertise with advanced knowledge of quality systems (change control, deviations, investigations, root cause analysis, CAPA and risk assessments)
+ Demonstrates judgment, technical competence and knowledge critical for role
+ Good computer skills with MS Office and Adobe Acrobat
+ Strong organizational skills, including attention to detail and ability to meet deadlines
+ Able to rigorously apply, follow and maintain rules, regulatory requirements, procedures and processes
+ Must be able to work independently and as part of a team
+ Able to multi-task while collaborating to achieve and exceed goals
+ Leads improvement initiatives for organization's practices, processes and quality
+ Supports colleagues and actively engages with colleagues
+ Facilitates cross-functional collaboration and manages assigned projects
+ Good oral and written communication skills and good interpersonal skills
+ Bilingual in both French and English (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA).
Politique de confidentialité de Canada - Careers
Canada Careers Privacy Notice ( NORTH AMERICA : Canada : Montreal:CAQUEBEC - Quebec**
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:** TECHNICAL
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4
Superviseur de fractionnement / Fractionation Supervisor
Posted 4 days ago
Job Viewed
Job Description
Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Titre du poste : Superviseur, Fractionnement
Relève de : Gestionnaire du fractionnement
Le Superviseur, Fractionnement est responsable des quarts de travail quotidiens qui se déroulent dans la zone de fractionnement de la production de l'installation de fabrication de Grifols Canada Thérapeutiques (GCT). Il sera chargé de veiller à ce que les objectifs de qualité, de sécurité, de prestation et de productivité du service soient atteints. Le Superviseur, Fractionnement, connaît très bien les GMPc et les procédés de fabrication du fractionnement des protéines. Ce rôle supervise tous les membres de l'équipe qui leur sont assignés. Le rôle est responsable d'enquêter et de remplir les avis de qualité, de rédiger et d'examiner les PON et les dossiers de production par lots.
Principales tâches et responsabilités
+ Diriger les activités quotidiennes du quart de travail de fabrication s'assure que toutes les tâches sont assignées et fait le suivi tout au long du quart de travail.
+ S'assurer que les avis (de qualité ou entretien préventif) sont émis en temps opportun et que l'enquête est terminée en temps opportun
+ Responsable de s'assurer que tous les calendriers de fabrication, les produits et les matériaux sont livrés
+ Formation du personnel de fabrication du fractionnement sur les activités de procédé, y compris les exigences de sécurité et les exigences cBPF. Cerner les lacunes techniques et non techniques en matière de développement et mettre en œuvre les plans et les cibles applicables. Examiner les cas de sécurité et déterminer ou mettre en œuvre des mesures correctives.
+ Élabore, forme et surveille le personnel de fractionnement pour s'assurer que les produits sont fabriqués conformément aux exigences réglementaires définies, aux procédures de GCT et aux règlements GxP.
+ Assurer la conformité aux procédures et aux politiques d'exploitation du site, y compris les protocoles de santé et de sécurité, ainsi qu'à tous les règlements des autorités sanitaires fédérales liés aux opérations de fabrication de fractionnement.
+ Comprend et adhère aux bonnes pratiques de documentation (BPD)
+ Coordonner et rédiger les examens des documents liés aux lots, y compris les dossiers de lots et les PON
+ Exécuter les affectations du système de gestion de la qualité (CAPA, contrôle des changements, procédures opérationnelles normalisées, etc.) pour les clôturer à temps
+ Assurez-vous que tout l'équipement fonctionne correctement. Demandes de réparation ou de modification de l'équipement et des installations
+ Résoudre les problèmes opérationnels et d'équipement et faire des recommandations. Coordonne également les réparations d'urgence, les changements et les activités d'entretien préventif avec l'équipe des services publics.
+ Coordonner les activités de fabrication avec les autres services. Cela comprend la collaboration étroite avec le contrôle de la qualité, la gestion des matériaux, l'assurance de la qualité, la validation, etc.
Qualifications requises :
+ Diplôme collégial ou technique obligatoire. Baccalauréat en sciences, en génie ou dans un domaine connexe de préférence. Expérience antérieure dans la fabrication de protéines biologiques par fractionnement est un atout.
+ 1 à 3 ans d'expérience en leadership/superviseur de fabrication dans un environnement biopharmaceutique cGMP.
+ Bonne compréhension des principes de fonctionnement de la plupart des équipements de traitement. Solide connaissance des principes techniques et scientifiques associés aux processus aseptiques.
+ Bonne connaissance des systèmes de contrôle automatisés.
+ Bonne connaissance des exigences et des règlements des installations cGMP, de l'OSHA, de l'EPA et de la FDA.
+ Bonne connaissance des opérations aseptiques, des statistiques, de la conception d'équipements, du contrôle des procédés, de la mise à l'échelle des procédés, des procédés pharmaceutiques aseptiques et de la validation des équipements.
+ Capacité de dépanner et d'entretenir les systèmes, l'équipement et les processus de fabrication.
+ Capacité à s'habiller de manière aseptique pour les opérations en salle blanche.
+ Capacité à réagir rapidement pour comprendre et résoudre les problèmes.
+ Excellentes compétences en communication et en documentation, en organisation et en dépannage
+ Capacité à lire, comprendre et suivre avec précision les SOP et les lignes directrices de l'entreprise
+ Doit posséder de bonnes à excellentes compétences en écriture et en informatique avec une base de connaissances et une maîtrise de Microsoft Word, Excel, Power Point et Project.
+ Bilinguisme (français et anglais) parlé et écrit (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA).
Position title: Supervisor, Fractionation
Reports to: Fractionation Manager
The Supervisor, Fractionation, is responsible for the daily manufacturing shift activities occurring in the Fractionation area of Production within the Grifols Canada Therapeutics (GCT) Manufacturing Facility. They will be responsible for ensuring department quality, safety, delivery and productivity objectives are met. The Supervisor, Fractionation is highly knowledgeable in cGMPs and protein Fractionation manufacturing processes. This role supervises all team members assigned to them. The role is responsible for investigating and completing Quality notifications, drafting and reviewing SOPs and batch production records.
Key Duties and Responsibilities
+ Leading and directing the daily manufacturing shift activities ensure all tasks are assigned and follows up throughout the shift on progress.
+ Ensure notifications (quality or preventative maintenance) are issued in a timely manner and completes investigation in a timely manner
+ Responsible for ensuring all manufacturing schedules, products and materials are delivered
+ Trains Fractionation manufacturing personnel on process activities, including safety requirements and cGMP requirements. Identify technical and non-technical development gaps and implement applicable plans and targets. Reviews safety cases and identifies or implements corrective actions.
+ Develops, trains, and monitors Fractionation personnel to ensure products are manufactured in accordance with defined regulatory requirements, GCT's procedures, and GxP regulations.
+ Ensures compliance with site operating procedures and policies, including health and safety protocols, in addition to all federal health authority regulations related to Fractionation manufacturing operations.
+ Understands and adheres to Good Documentation Practices (GDP)
+ Coordinates and drafts reviews of batch-related documents, including batch records and SOPs
+ Executes quality management system assignments (CAPA, change control, standard operating procedures, etc.) to close on time
+ Make sure all equipment is working properly. Requests for equipment and facility repairs, or modifications
+ Resolves operational and equipment issues and makes recommendations. Also coordinates emergency repairs, changes, and preventative maintenance activities with the utility team.
+ Coordinates manufacturing activities with other departments. This includes working closely with quality control, materials management, quality assurance, validation, etc.
Qualifications:
+ CEGEP or technical degree mandatory. BS degree in Science, Engineering or related field preferred. Previous experience in biologics protein fractionation manufacturing is an asset.
+ 1 to 3 years manufacturing leadership/supervisor experience in a cGMP biopharmaceutical environment.
+ Good understanding of the operating principles of most process equipment. Strong knowledge of technical and scientific principles associated with aseptic processing.
+ Good knowledge of automated control systems.
+ Good knowledge of cGMP, OSHA, EPA, and FDA facility requirements and regulations.
+ Good knowledge of aseptic operations, statistics, equipment design, process control, process scale-up, aseptic pharmaceutical processes, and equipment validations.
+ Ability to troubleshoot and maintain manufacturing systems, equipment, and processes.
+ Ability to dress aseptically for cleanroom operations.
+ Ability to react quickly to understand and solve problems.
+ Excellent communication and documentation skills, organizational and troubleshooting skills
+ Ability to accurately read, understand, and follow company SOPs and guidelines
+ Must possess good to excellent writing and computer skills with a knowledge base and proficiency in Microsoft Word, Excel, Power Point, and Project.
+ Bilingualism (French and English) both spoken and written (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA).
Politique de confidentialité de Canada - Careers ( Careers Privacy Notice
**Location: NORTH AMERICA : Canada : Montreal:CAQUEBEC - Quebec**
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:** MANUFACTURING
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Titre du poste : Superviseur, Fractionnement
Relève de : Gestionnaire du fractionnement
Le Superviseur, Fractionnement est responsable des quarts de travail quotidiens qui se déroulent dans la zone de fractionnement de la production de l'installation de fabrication de Grifols Canada Thérapeutiques (GCT). Il sera chargé de veiller à ce que les objectifs de qualité, de sécurité, de prestation et de productivité du service soient atteints. Le Superviseur, Fractionnement, connaît très bien les GMPc et les procédés de fabrication du fractionnement des protéines. Ce rôle supervise tous les membres de l'équipe qui leur sont assignés. Le rôle est responsable d'enquêter et de remplir les avis de qualité, de rédiger et d'examiner les PON et les dossiers de production par lots.
Principales tâches et responsabilités
+ Diriger les activités quotidiennes du quart de travail de fabrication s'assure que toutes les tâches sont assignées et fait le suivi tout au long du quart de travail.
+ S'assurer que les avis (de qualité ou entretien préventif) sont émis en temps opportun et que l'enquête est terminée en temps opportun
+ Responsable de s'assurer que tous les calendriers de fabrication, les produits et les matériaux sont livrés
+ Formation du personnel de fabrication du fractionnement sur les activités de procédé, y compris les exigences de sécurité et les exigences cBPF. Cerner les lacunes techniques et non techniques en matière de développement et mettre en œuvre les plans et les cibles applicables. Examiner les cas de sécurité et déterminer ou mettre en œuvre des mesures correctives.
+ Élabore, forme et surveille le personnel de fractionnement pour s'assurer que les produits sont fabriqués conformément aux exigences réglementaires définies, aux procédures de GCT et aux règlements GxP.
+ Assurer la conformité aux procédures et aux politiques d'exploitation du site, y compris les protocoles de santé et de sécurité, ainsi qu'à tous les règlements des autorités sanitaires fédérales liés aux opérations de fabrication de fractionnement.
+ Comprend et adhère aux bonnes pratiques de documentation (BPD)
+ Coordonner et rédiger les examens des documents liés aux lots, y compris les dossiers de lots et les PON
+ Exécuter les affectations du système de gestion de la qualité (CAPA, contrôle des changements, procédures opérationnelles normalisées, etc.) pour les clôturer à temps
+ Assurez-vous que tout l'équipement fonctionne correctement. Demandes de réparation ou de modification de l'équipement et des installations
+ Résoudre les problèmes opérationnels et d'équipement et faire des recommandations. Coordonne également les réparations d'urgence, les changements et les activités d'entretien préventif avec l'équipe des services publics.
+ Coordonner les activités de fabrication avec les autres services. Cela comprend la collaboration étroite avec le contrôle de la qualité, la gestion des matériaux, l'assurance de la qualité, la validation, etc.
Qualifications requises :
+ Diplôme collégial ou technique obligatoire. Baccalauréat en sciences, en génie ou dans un domaine connexe de préférence. Expérience antérieure dans la fabrication de protéines biologiques par fractionnement est un atout.
+ 1 à 3 ans d'expérience en leadership/superviseur de fabrication dans un environnement biopharmaceutique cGMP.
+ Bonne compréhension des principes de fonctionnement de la plupart des équipements de traitement. Solide connaissance des principes techniques et scientifiques associés aux processus aseptiques.
+ Bonne connaissance des systèmes de contrôle automatisés.
+ Bonne connaissance des exigences et des règlements des installations cGMP, de l'OSHA, de l'EPA et de la FDA.
+ Bonne connaissance des opérations aseptiques, des statistiques, de la conception d'équipements, du contrôle des procédés, de la mise à l'échelle des procédés, des procédés pharmaceutiques aseptiques et de la validation des équipements.
+ Capacité de dépanner et d'entretenir les systèmes, l'équipement et les processus de fabrication.
+ Capacité à s'habiller de manière aseptique pour les opérations en salle blanche.
+ Capacité à réagir rapidement pour comprendre et résoudre les problèmes.
+ Excellentes compétences en communication et en documentation, en organisation et en dépannage
+ Capacité à lire, comprendre et suivre avec précision les SOP et les lignes directrices de l'entreprise
+ Doit posséder de bonnes à excellentes compétences en écriture et en informatique avec une base de connaissances et une maîtrise de Microsoft Word, Excel, Power Point et Project.
+ Bilinguisme (français et anglais) parlé et écrit (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA).
Position title: Supervisor, Fractionation
Reports to: Fractionation Manager
The Supervisor, Fractionation, is responsible for the daily manufacturing shift activities occurring in the Fractionation area of Production within the Grifols Canada Therapeutics (GCT) Manufacturing Facility. They will be responsible for ensuring department quality, safety, delivery and productivity objectives are met. The Supervisor, Fractionation is highly knowledgeable in cGMPs and protein Fractionation manufacturing processes. This role supervises all team members assigned to them. The role is responsible for investigating and completing Quality notifications, drafting and reviewing SOPs and batch production records.
Key Duties and Responsibilities
+ Leading and directing the daily manufacturing shift activities ensure all tasks are assigned and follows up throughout the shift on progress.
+ Ensure notifications (quality or preventative maintenance) are issued in a timely manner and completes investigation in a timely manner
+ Responsible for ensuring all manufacturing schedules, products and materials are delivered
+ Trains Fractionation manufacturing personnel on process activities, including safety requirements and cGMP requirements. Identify technical and non-technical development gaps and implement applicable plans and targets. Reviews safety cases and identifies or implements corrective actions.
+ Develops, trains, and monitors Fractionation personnel to ensure products are manufactured in accordance with defined regulatory requirements, GCT's procedures, and GxP regulations.
+ Ensures compliance with site operating procedures and policies, including health and safety protocols, in addition to all federal health authority regulations related to Fractionation manufacturing operations.
+ Understands and adheres to Good Documentation Practices (GDP)
+ Coordinates and drafts reviews of batch-related documents, including batch records and SOPs
+ Executes quality management system assignments (CAPA, change control, standard operating procedures, etc.) to close on time
+ Make sure all equipment is working properly. Requests for equipment and facility repairs, or modifications
+ Resolves operational and equipment issues and makes recommendations. Also coordinates emergency repairs, changes, and preventative maintenance activities with the utility team.
+ Coordinates manufacturing activities with other departments. This includes working closely with quality control, materials management, quality assurance, validation, etc.
Qualifications:
+ CEGEP or technical degree mandatory. BS degree in Science, Engineering or related field preferred. Previous experience in biologics protein fractionation manufacturing is an asset.
+ 1 to 3 years manufacturing leadership/supervisor experience in a cGMP biopharmaceutical environment.
+ Good understanding of the operating principles of most process equipment. Strong knowledge of technical and scientific principles associated with aseptic processing.
+ Good knowledge of automated control systems.
+ Good knowledge of cGMP, OSHA, EPA, and FDA facility requirements and regulations.
+ Good knowledge of aseptic operations, statistics, equipment design, process control, process scale-up, aseptic pharmaceutical processes, and equipment validations.
+ Ability to troubleshoot and maintain manufacturing systems, equipment, and processes.
+ Ability to dress aseptically for cleanroom operations.
+ Ability to react quickly to understand and solve problems.
+ Excellent communication and documentation skills, organizational and troubleshooting skills
+ Ability to accurately read, understand, and follow company SOPs and guidelines
+ Must possess good to excellent writing and computer skills with a knowledge base and proficiency in Microsoft Word, Excel, Power Point, and Project.
+ Bilingualism (French and English) both spoken and written (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA).
Politique de confidentialité de Canada - Careers ( Careers Privacy Notice
**Location: NORTH AMERICA : Canada : Montreal:CAQUEBEC - Quebec**
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:** MANUFACTURING
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5
Spécialiste, Assurance Qualité - Plasma - Quality Assurance Specialist - Plasma
Posted 4 days ago
Job Viewed
Job Description
Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Titre du poste : Spécialiste, Assurance Qualité
Relève de : Gestionnaire, Assurance Qualité
Le Spécialiste AQ - Plasma soutiendra le Centre Logistique Plasma de GCT par diverses tâches liées à la libération des produits plasmatiques, aux vérifications post-don, à la supervision qualité et aux inspections. Le Spécialiste AQ contribuera à la préparation et au soutien des inspections réglementaires, des audits internes ainsi que d'autres projets proactifs de gestion de la qualité.
Il/elle participera également à l'investigation des écarts concernant les matériaux et le processus de traitement du plasma, en veillant à ce que ces écarts soient traités de manière appropriée, garantissant ainsi un produit fini de meilleure qualité pour les clients potentiels.
En outre, les responsabilités suivantes seront également attendues :
**Principales fonctions et responsabilités :**
+ Recevoir, enregistrer et évaluer les alertes « lookback » entrantes. Maintenir la documentation des alertes actives et clôturées. S'assurer que toute la documentation provenant du centre de dons est lisible et correcte.
+ Veiller à ce que les unités de plasma identifiées dans l'alerte « lookback » et faisant partie de l'inventaire interne des centres logistiques (PLC) soient marquées pour retrait dans le système de gestion des stocks.
+ Veiller à ce que toutes les notifications d'alerte « lookback » reçues soient traitées conformément aux réglementations applicables et aux Procédures Opératoires Normalisées (SOP) établies.
+ Assister à l'investigation et à la clôture des plaintes clients initiées au centre logistique (PLC).
+ Enquêter et rédiger des rapports sur les produits en cours de fabrication/finis et les processus qui ne respectent pas les spécifications de qualité, et documenter ces écarts dans un rapport de déviation.
+ Participer à la rédaction ou à la révision des politiques et des procédures opératoires normalisées (SOP) liées au traitement du plasma et aux systèmes qualité au GPLC, y compris la participation à la révision annuelle des documents.
+ Assister à la formation des nouveaux employés en assurance qualité et à la reformation des employés actuels lorsque nécessaire.
+ Être responsable de la libération qualité (QA) du plasma provenant du PLC et vérifier que tout le contenu des expéditions respecte les procédures opératoires normalisées, les exigences réglementaires et celles des clients avant la libération.
+ Créer le certificat de conformité du lot de plasma en utilisant GPOPQD et mettre à jour les méthodes de test SGP.
+ Examiner et vérifier la documentation des températures du centre et du transport afin de garantir la conformité aux spécifications de température appropriées pour la libération des lots
+ Débloquer les unités dans SGP et compléter l'évaluation de la conformité du plasma.
+ Assister l'équipe de direction dans les activités de recherche, telles que l'examen des donneurs sous audit et la création de certificats de conformité pour faciliter la libération des lots.
+ Effectuer et soutenir les recherches liées aux alertes « lookback » ainsi que l'évaluation des donneurs sous audit.
+ Effectuer la révision qualité des alertes « lookback » (si applicable).
+ Effectuer la révision qualité des documents identifiés par la gestion de la qualité
+ Assumer des responsabilités supplémentaires dans le cadre du programme de système qualité, telles qu'enseignées et assignées.
**Exigences requises :**
+ Baccalauréat en sciences minimum (de préférence en microbiologie, chimie, biologie) ou expérience professionnelle équivalente ;
+ Au moins 3 ans d'expérience en assurance qualité au sein de l'industrie manufacturière biopharmaceutique ou pharmaceutique ;
+ Expertise de niveau Spécialiste avec une connaissance avancée des systèmes qualité (contrôle des changements, déviations, investigations, analyse des causes fondamentales, CAPA et évaluations des risques) ;
+ Faire preuve de jugement, de compétence technique et de connaissances essentielles au rôle ;
+ Bonnes compétences informatiques avec MS Office et Adobe Acrobat ;
+ Solides compétences organisationnelles, y compris le souci du détail et la capacité à respecter les délais ;
+ Capable d'appliquer, de suivre et de maintenir rigoureusement les règles, les exigences réglementaires, les procédures et les processus ;
+ Capable de travailler de manière autonome et en équipe ;
+ Capable d'effectuer plusieurs tâches à la fois tout en collaborant pour atteindre et dépasser les objectifs ;
+ Diriger les initiatives d'amélioration des pratiques, des processus et de la qualité de l'entreprise ;
+ Soutenir et collaborer activement avec ses collègues ;
+ Faciliter la collaboration interfonctionnelle et gérer les projets assignés ;
+ Bonnes compétences en communication orale et écrite et bonne aptitudes relationnelles ;
+ Bilingue en français et en anglais (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA).
Position title: Quality Assurance Specialist
Reports to: Quality Assurance Manager
The Quality Assurance Specialist (QA) - Plasma, will support the Plasma Logistics Center at GCT through various tasks related to plasma product release, post-donation lookbacks, quality oversight and inspection. The QA specialist will assist in supporting regulatory inspections, internal audits, and other proactive quality management projects. He/she will also assist with investigating deviations of both materials and the plasma processing and ensure these deviations are appropriately handled; therefore, assuring a better finished product for prospective customers. In addition, the following responsibilities will also be expected:
**Key Duties and Responsibilities**
+ Receives, logs and evaluates incoming lookback alerts. Maintains documentation of active and closed alerts. Ensures all documentation from donor center is legible and correct.
+ Ensures plasma units identified in the lookback alert that are part of the in-house inventory at the PLCs are marked for removal in inventory control system.
+ Ensure all Lookback Alert Notifications received are processed in accordance with applicable regulations and established Standard Operating Procedures (SOP).
+ Assist with investigation and completion of customer complaints initiated at the PLC.
+ Investigates and reports in-process/final product and processes that do not meet quality specifications and document in a deviation report.
+ Participates in the writing or revision of policies and standard operating procedures related to Plasma processing and Quality Systems at GPLC, including participation in annual document review
+ Assist with training of new Quality personnel & retraining of current employees when needed
+ Responsible for the QA release of plasma from PLC and verifies that all shipment contents meet standard operating procedures, regulatory and customer requirements prior to release.
+ Create Plasma Lot Certificate of Compliance using GPOPQD and updates to SGP test methods
+ Reviews and verifies center and transportation temperature documentation to ensure conformance to appropriate temperature specifications for Lot release.
+ Unblock units in SGP and complete plasma suitability.
+ Assist Management team with research activities such as Donors Under Audit, creation of Certificate of Compliance to assist with lot release.
+ Perform and support Lookback research and donors under audit evaluation
+ Perform QA review of Lookbacks (if applicable)
+ Performs quality review of documents as identified by Quality Management.
+ Perform additional Quality System program responsibilities as trained on and assigned
**Qualifications:**
+ Education: At minimum, must have a B. Science, (Preferred: Microbiology, Chemistry, Biology) or equivalent job experience
+ At least 3 years' experience in QA within the Biopharmaceutical or Pharmaceutical manufacturing Industry
+ Specialist level expertise with advanced knowledge of quality systems (change control, deviations, investigations, root cause analysis, CAPA and risk assessments)
+ Demonstrates judgment, technical competence and knowledge critical for role
+ Good computer skills with MS Office and Adobe Acrobat
+ Strong organizational skills, including attention to detail and ability to meet deadlines
+ Able to rigorously apply, follow and maintain rules, regulatory requirements, procedures and processes
+ Must be able to work independently and as part of a team
+ Able to multi-task while collaborating to achieve and exceed goals
+ Leads improvement initiatives for organization's practices, processes and quality
+ Supports colleagues and actively engages with colleagues
+ Facilitates cross-functional collaboration and manages assigned projects
+ Good oral and written communication skills and good interpersonal skills
+ Bilingual in both French and English (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA).
Politique de confidentialité de Canada - Careers
Canada Careers Privacy Notice ( NORTH AMERICA : Canada : Montreal:CAQUEBEC - Quebec**
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:** TECHNICAL
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Titre du poste : Spécialiste, Assurance Qualité
Relève de : Gestionnaire, Assurance Qualité
Le Spécialiste AQ - Plasma soutiendra le Centre Logistique Plasma de GCT par diverses tâches liées à la libération des produits plasmatiques, aux vérifications post-don, à la supervision qualité et aux inspections. Le Spécialiste AQ contribuera à la préparation et au soutien des inspections réglementaires, des audits internes ainsi que d'autres projets proactifs de gestion de la qualité.
Il/elle participera également à l'investigation des écarts concernant les matériaux et le processus de traitement du plasma, en veillant à ce que ces écarts soient traités de manière appropriée, garantissant ainsi un produit fini de meilleure qualité pour les clients potentiels.
En outre, les responsabilités suivantes seront également attendues :
**Principales fonctions et responsabilités :**
+ Recevoir, enregistrer et évaluer les alertes « lookback » entrantes. Maintenir la documentation des alertes actives et clôturées. S'assurer que toute la documentation provenant du centre de dons est lisible et correcte.
+ Veiller à ce que les unités de plasma identifiées dans l'alerte « lookback » et faisant partie de l'inventaire interne des centres logistiques (PLC) soient marquées pour retrait dans le système de gestion des stocks.
+ Veiller à ce que toutes les notifications d'alerte « lookback » reçues soient traitées conformément aux réglementations applicables et aux Procédures Opératoires Normalisées (SOP) établies.
+ Assister à l'investigation et à la clôture des plaintes clients initiées au centre logistique (PLC).
+ Enquêter et rédiger des rapports sur les produits en cours de fabrication/finis et les processus qui ne respectent pas les spécifications de qualité, et documenter ces écarts dans un rapport de déviation.
+ Participer à la rédaction ou à la révision des politiques et des procédures opératoires normalisées (SOP) liées au traitement du plasma et aux systèmes qualité au GPLC, y compris la participation à la révision annuelle des documents.
+ Assister à la formation des nouveaux employés en assurance qualité et à la reformation des employés actuels lorsque nécessaire.
+ Être responsable de la libération qualité (QA) du plasma provenant du PLC et vérifier que tout le contenu des expéditions respecte les procédures opératoires normalisées, les exigences réglementaires et celles des clients avant la libération.
+ Créer le certificat de conformité du lot de plasma en utilisant GPOPQD et mettre à jour les méthodes de test SGP.
+ Examiner et vérifier la documentation des températures du centre et du transport afin de garantir la conformité aux spécifications de température appropriées pour la libération des lots
+ Débloquer les unités dans SGP et compléter l'évaluation de la conformité du plasma.
+ Assister l'équipe de direction dans les activités de recherche, telles que l'examen des donneurs sous audit et la création de certificats de conformité pour faciliter la libération des lots.
+ Effectuer et soutenir les recherches liées aux alertes « lookback » ainsi que l'évaluation des donneurs sous audit.
+ Effectuer la révision qualité des alertes « lookback » (si applicable).
+ Effectuer la révision qualité des documents identifiés par la gestion de la qualité
+ Assumer des responsabilités supplémentaires dans le cadre du programme de système qualité, telles qu'enseignées et assignées.
**Exigences requises :**
+ Baccalauréat en sciences minimum (de préférence en microbiologie, chimie, biologie) ou expérience professionnelle équivalente ;
+ Au moins 3 ans d'expérience en assurance qualité au sein de l'industrie manufacturière biopharmaceutique ou pharmaceutique ;
+ Expertise de niveau Spécialiste avec une connaissance avancée des systèmes qualité (contrôle des changements, déviations, investigations, analyse des causes fondamentales, CAPA et évaluations des risques) ;
+ Faire preuve de jugement, de compétence technique et de connaissances essentielles au rôle ;
+ Bonnes compétences informatiques avec MS Office et Adobe Acrobat ;
+ Solides compétences organisationnelles, y compris le souci du détail et la capacité à respecter les délais ;
+ Capable d'appliquer, de suivre et de maintenir rigoureusement les règles, les exigences réglementaires, les procédures et les processus ;
+ Capable de travailler de manière autonome et en équipe ;
+ Capable d'effectuer plusieurs tâches à la fois tout en collaborant pour atteindre et dépasser les objectifs ;
+ Diriger les initiatives d'amélioration des pratiques, des processus et de la qualité de l'entreprise ;
+ Soutenir et collaborer activement avec ses collègues ;
+ Faciliter la collaboration interfonctionnelle et gérer les projets assignés ;
+ Bonnes compétences en communication orale et écrite et bonne aptitudes relationnelles ;
+ Bilingue en français et en anglais (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA).
Position title: Quality Assurance Specialist
Reports to: Quality Assurance Manager
The Quality Assurance Specialist (QA) - Plasma, will support the Plasma Logistics Center at GCT through various tasks related to plasma product release, post-donation lookbacks, quality oversight and inspection. The QA specialist will assist in supporting regulatory inspections, internal audits, and other proactive quality management projects. He/she will also assist with investigating deviations of both materials and the plasma processing and ensure these deviations are appropriately handled; therefore, assuring a better finished product for prospective customers. In addition, the following responsibilities will also be expected:
**Key Duties and Responsibilities**
+ Receives, logs and evaluates incoming lookback alerts. Maintains documentation of active and closed alerts. Ensures all documentation from donor center is legible and correct.
+ Ensures plasma units identified in the lookback alert that are part of the in-house inventory at the PLCs are marked for removal in inventory control system.
+ Ensure all Lookback Alert Notifications received are processed in accordance with applicable regulations and established Standard Operating Procedures (SOP).
+ Assist with investigation and completion of customer complaints initiated at the PLC.
+ Investigates and reports in-process/final product and processes that do not meet quality specifications and document in a deviation report.
+ Participates in the writing or revision of policies and standard operating procedures related to Plasma processing and Quality Systems at GPLC, including participation in annual document review
+ Assist with training of new Quality personnel & retraining of current employees when needed
+ Responsible for the QA release of plasma from PLC and verifies that all shipment contents meet standard operating procedures, regulatory and customer requirements prior to release.
+ Create Plasma Lot Certificate of Compliance using GPOPQD and updates to SGP test methods
+ Reviews and verifies center and transportation temperature documentation to ensure conformance to appropriate temperature specifications for Lot release.
+ Unblock units in SGP and complete plasma suitability.
+ Assist Management team with research activities such as Donors Under Audit, creation of Certificate of Compliance to assist with lot release.
+ Perform and support Lookback research and donors under audit evaluation
+ Perform QA review of Lookbacks (if applicable)
+ Performs quality review of documents as identified by Quality Management.
+ Perform additional Quality System program responsibilities as trained on and assigned
**Qualifications:**
+ Education: At minimum, must have a B. Science, (Preferred: Microbiology, Chemistry, Biology) or equivalent job experience
+ At least 3 years' experience in QA within the Biopharmaceutical or Pharmaceutical manufacturing Industry
+ Specialist level expertise with advanced knowledge of quality systems (change control, deviations, investigations, root cause analysis, CAPA and risk assessments)
+ Demonstrates judgment, technical competence and knowledge critical for role
+ Good computer skills with MS Office and Adobe Acrobat
+ Strong organizational skills, including attention to detail and ability to meet deadlines
+ Able to rigorously apply, follow and maintain rules, regulatory requirements, procedures and processes
+ Must be able to work independently and as part of a team
+ Able to multi-task while collaborating to achieve and exceed goals
+ Leads improvement initiatives for organization's practices, processes and quality
+ Supports colleagues and actively engages with colleagues
+ Facilitates cross-functional collaboration and manages assigned projects
+ Good oral and written communication skills and good interpersonal skills
+ Bilingual in both French and English (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA).
Politique de confidentialité de Canada - Careers
Canada Careers Privacy Notice ( NORTH AMERICA : Canada : Montreal:CAQUEBEC - Quebec**
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:** TECHNICAL
Is this job a match or a miss?
Apply Now
6
Directeur des Affaires Corporatives Canada Corporate Affairs Director
Mississauga
Grifols Shared Services North America, Inc
Posted 4 days ago
Job Viewed
Job Description
Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
**DIRECTEUR(TRICE) DES AFFAIRES CORPORATIVES CANADA (AFFAIRES GOUVERNEMENTALES ET RELATIONS AVEC LES PATIENTS)**
**MISSION**
Grifols est une entreprise mondiale du secteur de la santé engagée à améliorer les résultats de santé grâce à une approche centrée sur le patient.
Le ou la Directeur(trice) des Affaires Corporatives Canada est responsable d'établir et de consolider la présence des Affaires corporatives de Grifols au Canada en assurant, comme priorité, la mise en œuvre locale de la stratégie de relations avec les patients, tout en soutenant les initiatives d'affaires gouvernementales en coordination avec les équipes mondiales et les partenaires de coentreprise (CBS).
Le poste sera principalement axé sur le développement de partenariats de confiance avec les patients, le renforcement de la réputation de Grifols, ainsi que sur la promotion d'une meilleure compréhension des besoins des patients et de la valeur des médicaments dérivés du plasma (MDP) au sein de l'écosystème de la santé, en parfaite cohérence avec la stratégie et le positionnement internationaux de l'entreprise.
Cette personne agira comme point d'ancrage de l'exécution locale et relèvera des Affaires corporatives internationales, basées au siège social de l'entreprise. Elle traduira les priorités mondiales en initiatives concrètes et adaptées au contexte canadien.
**ENVIRONNEMENT**
+ Nouveau poste créé dans un marché prioritaire stratégique, auparavant géré depuis les États-Unis.
+ Niveau élevé de coordination avec les équipes internationales des Relations avec les patients et des Affaires gouvernementales.
+ Collaboration interfonctionnelle avec les équipes des Affaires médicales, de l'Accès au marché, des Communications corporatives, des Affaires juridiques et de la Conformité.
+ Interaction externe avec les organisations de patients, les professionnels de la santé, les donneurs, les organismes de réglementation et les associations industrielles, en étroite coordination avec CBS.
**FONCTIONS ET RESPONSABILITÉS**
**1. Relations avec les patients (principal axe de responsabilité)**
+ Mettre en œuvre la stratégie internationale de relations avec les patients au Canada, en assurant une exécution locale solide et un impact mesurable.
+ Développer et maintenir des relations de confiance durables avec les organisations de patients et les parties prenantes clés.
+ Positionner Grifols comme un partenaire crédible, responsable et centré sur le patient au sein de l'écosystème canadien.
+ Identifier et mettre en œuvre des collaborations stratégiques, initiatives éducatives et programmes d'engagement des patients.
+ Recueillir, consolider et valoriser les perspectives et besoins des patients afin d'orienter les priorités internes et la prise de décision.
+ Représenter la voix du patient à l'interne, en assurant l'alignement avec l'approche mondiale des Relations avec les patients.
+ Coordonner les activités destinées aux patients (événements, comités consultatifs, partenariats et collaborations).
+ Veiller à ce que toutes les activités soient réalisées dans le plein respect des politiques internes et des réglementations externes.
Sensibilisation au plasma et lien « du donneur au patient » (Vein-to-Vein)
+ Piloter des initiatives visant à accroître la sensibilisation au don de plasma et à son impact vital.
+ Promouvoir le concept du lien « du donneur au patient » entre les donneurs de plasma et les patients.
+ Collaborer avec les centres de collecte, les organisations de patients et les autres parties prenantes afin de renforcer ce message à l'échelle locale.
+ Adapter et mettre en œuvre les meilleures pratiques provenant d'autres pays (par exemple l'Allemagne) dans le contexte canadien.
**2. Stratégie des Affaires corporatives et alignement interfonctionnel**
+ Élaborer et exécuter le plan local des Affaires corporatives, aligné sur la stratégie et les priorités internationales.
+ Assurer la cohérence du positionnement, des messages et de l'engagement des parties prenantes.
+ Agir comme principal lien entre les équipes du Canada et des Affaires corporatives internationales.
+ Contribuer au renforcement de la réputation de Grifols et à l'établissement d'une confiance durable auprès des parties prenantes.
**3. Affaires gouvernementales et politiques publiques (rôle de soutien avec évolution progressive des responsabilités)**
+ Assurer une veille et analyser le contexte réglementaire et politique canadien lié au plasma, aux médicaments dérivés du plasma et à l'accès aux soins de santé.
+ Soutenir la stratégie d'Affaires gouvernementales en coordination avec le siège social et les partenaires de coentreprise (CBS).
+ Interagir au besoin avec les décideurs publics, les organismes de réglementation et les intervenants de l'industrie.
+ Identifier les risques et les occasions ayant une incidence sur l'accès, la durabilité et l'innovation.
**4. Engagement des parties prenantes et représentation externe**
+ Développer et gérer les relations avec :
+ Les organisations de patients
+ Les professionnels de la santé
+ Les décideurs publics et les organismes de réglementation
+ Les associations de l'industrie et les ONG
+ Représenter Grifols dans les forums pertinents, associations professionnelles, groupes de travail et événements, lorsque requis.
**5. Veille, rapports et conformité**
+ Surveiller les tendances liées aux besoins des patients, aux évolutions des politiques publiques et aux attentes des parties prenantes.
+ Fournir des analyses locales et des recommandations stratégiques aux Affaires corporatives internationales.
+ Préparer des rapports réguliers sur les activités et les résultats obtenus.
+ Veiller au respect des normes de conformité, de transparence et d'éthique.
**EXPÉRIENCE**
+ Plus de 10 ans d'expérience.
+ Expérience en relations avec les patients, défense des intérêts des patients, affaires corporatives ou autres fonctions connexes dans le domaine de la santé.
+ Expérience démontrée dans l'établissement de partenariats avec des organisations de patients.
+ Une expérience en affaires gouvernementales ou affaires publiques constitue un atout important.
+ Une solide compréhension du système de santé canadien est fortement souhaitée.
**FORMATION ACADÉMIQUE**
+ Baccalauréat en sciences de la vie, santé publique, science politique, droit, économie ou dans un domaine connexe.
+ Maîtrise en politiques publiques, économie de la santé ou domaine similaire : un atout.
**LANGUES**
+ Anglais : langue maternelle ou niveau courant
+ Français : langue maternelle ou bilingue
+ Espagnol : un atout
**COMPÉTENCES FONCTIONNELLES**
+ Excellentes aptitudes en gestion des parties prenantes et en développement de partenariats.
+ Solides compétences en communication, influence et négociation.
+ Capacité à traduire une stratégie mondiale en une exécution locale efficace.
+ Forte capacité de réflexion stratégique combinée à une orientation vers l'exécution.
+ Capacité à évoluer dans des environnements ambigus et en constante évolution avec un haut degré d'autonomie.
**QUALITÉS PERSONNELLES ET COMPÉTENCES COMPORTEMENTALES**
+ Forte orientation patient et grande empathie.
+ Esprit proactif, orienté vers les solutions et capacité d'adaptation.
+ Haut niveau d'intégrité et forte sensibilité aux exigences de conformité.
+ Esprit collaboratif et aisance dans un contexte multiculturel.
+ Capacité à travailler de manière autonome tout en assurant un alignement constant avec le siège social.
**CANADA CORPORATE AFFAIRS DIRECTOR (GOVERNMENT & PATIENT AFFAIRS)**
**MISSION**
Grifols is a global healthcare company committed to advancing health outcomes through a patient-centered approach.
The Canada Corporate Affairs Director is responsible for establishing and consolidating Grifols' Corporate Affairs presence in Canada by driving the local implementation of the company's Patient Affairs strategy as a priority, while supporting Government Affairs initiatives in coordination with global and joint-venture partners (CBS).
The role will focus on building trusted patient partnerships, strengthening Grifols' reputation, and ensuring that patient needs and the value of Plasma-Derived Medicinal Products (PDMPs) are understood and appropriately reflected across the healthcare ecosystem, in full alignment with the company's international strategy and positioning.
This position will act as the local execution anchor and reporting to International Corporate Affairs, based in the company's HQ, translating global priorities into impactful, locally adapted initiatives within the Canadian healthcare ecosystem.
**ENVIRONMENT**
+ Newly created role in a strategic priority market, previously managed from the US
+ High level of coordination with International Patient & Government Affairs
+ Cross-functional collaboration with Medical Affairs, Market Access, Corporate Communications, Legal and Compliance
+ External engagement with patient organizations, healthcare professionals, donors, regulators, and industry associations in full coordination with CBS
**FUNCTIONS AND RESPONSIBILITIES**
**1. Patient Affairs (Primary Focus)**
+ Implement the International Patient Affairs strategy in Canada, ensuring strong local execution and measurable impact
+ Build and maintain trusted, long-term relationships with patient organizations and key stakeholders
+ Position Grifols as a credible and responsible patient-centric partner within the Canadian ecosystem
+ Identify and execute strategic collaborations, education initiatives, and patient engagement programs
+ Capture, consolidate and elevate patient insights to inform internal priorities and decision-making
+ Represent the patient perspective internally, ensuring alignment with global Patient Affairs approach
+ Coordinate patient-facing activities (events, advisory boards, partnerships, collaborations)
+ Ensure all activities are conducted in full compliance with internal policies and external regulations
**Plasma Awareness & Vein-to-Vein Connection**
+ Drive initiatives to increase awareness of plasma donation and its life-saving impact
+ Promote the "vein-to-vein" connection between plasma donors and patients
+ Collaborate with donor centers, patient organizations and stakeholders to strengthen this narrative locally
+ Adapt and implement best practices from other countries (e.g. Germany) into the Canadian context
**2. Corporate Affairs Strategy & Cross-functional Alignment**
+ Develop and execute the local Corporate Affairs plan aligned with International strategy and priorities
+ Ensure consistency in positioning, messaging and stakeholder engagement
+ Act as a key liaison between Canada and International Corporate Affairs
+ Contribute to strengthening Grifols' reputation and long-term stakeholder trust
**3. Government & Policy Affairs (Supporting Role/** **Progressive Responsibility)**
+ Monitor and analyze the Canadian policy and regulatory landscape relevant to plasma, PDMPs and healthcare access
+ Support Government Affairs strategy in coordination with HQ and joint-venture partners (CBS)
+ Engage with policymakers, regulators and industry stakeholders as needed
+ Identify risks and opportunities impacting access, sustainability and innovation
**4. Stakeholder Engagement & External Representation**
+ Build and manage relationships with:
+ Patient organizations
+ Healthcare professionals
+ Policymakers and regulators
+ Industry associations and NGOs
+ Represent Grifols in relevant forums, professional associations, working groups and events, when appropriate
**5. Insights, Reporting & Compliance**
+ Monitor trends in patient needs, policy developments and stakeholder expectations
+ Provide local insights and strategic input to International Corporate Affairs
+ Prepare regular reports on activities and outcomes
+ Ensure adherence to compliance, transparency and ethical standards
**EXPERIENCE**
+ Years of Experience: 10+ years
+ Experience in Patient Affairs, patient advocacy, Corporate Affairs or related healthcare roles
+ Proven track record in building partnerships with patient organizations
+ Exposure to Government or Public Affairs activities is a strong plus
+ Solid understanding of the Canadian healthcare system strongly preferred
**ACADEMIC BACKGROUND**
+ Bachelor's degree in Life Sciences, Public Health, Political Science, Law, Economics or related field
+ Master's degree in Public Policy, Health Economics or similar is a plus
**LANGUAGES**
+ English: Native/fluent
+ French: Native/bilingual
+ Spanish: Nice to have
**FUNCTIONAL SKILLS**
+ Strong stakeholder engagement and partnership-building capabilities
+ Excellent communication, influencing and negotiation skills
+ Ability to translate global strategy into effective local execution
+ Strong strategic thinking combined with execution focus
+ Ability to operate in ambiguous, evolving environments with high autonomy
**PERSONAL ATTRIBUTES & COMPETENCIES**
+ Strong patient-centric mindset and empathy
+ Proactive, solution-oriented and adaptable
+ High level of integrity and compliance awareness
+ Collaborative and cross-cultural mindset
+ Ability to operate autonomously while ensuring alignment with HQ
\#LI-AC1
Politique de confidentialité de Canada - Careers ( Careers Privacy Notice
**Location: NORTH AMERICA : Canada : Mississauga:CATORONT - Canada Headquarters - Toronto**
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:** GENERAL MANAGEMENT
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
**DIRECTEUR(TRICE) DES AFFAIRES CORPORATIVES CANADA (AFFAIRES GOUVERNEMENTALES ET RELATIONS AVEC LES PATIENTS)**
**MISSION**
Grifols est une entreprise mondiale du secteur de la santé engagée à améliorer les résultats de santé grâce à une approche centrée sur le patient.
Le ou la Directeur(trice) des Affaires Corporatives Canada est responsable d'établir et de consolider la présence des Affaires corporatives de Grifols au Canada en assurant, comme priorité, la mise en œuvre locale de la stratégie de relations avec les patients, tout en soutenant les initiatives d'affaires gouvernementales en coordination avec les équipes mondiales et les partenaires de coentreprise (CBS).
Le poste sera principalement axé sur le développement de partenariats de confiance avec les patients, le renforcement de la réputation de Grifols, ainsi que sur la promotion d'une meilleure compréhension des besoins des patients et de la valeur des médicaments dérivés du plasma (MDP) au sein de l'écosystème de la santé, en parfaite cohérence avec la stratégie et le positionnement internationaux de l'entreprise.
Cette personne agira comme point d'ancrage de l'exécution locale et relèvera des Affaires corporatives internationales, basées au siège social de l'entreprise. Elle traduira les priorités mondiales en initiatives concrètes et adaptées au contexte canadien.
**ENVIRONNEMENT**
+ Nouveau poste créé dans un marché prioritaire stratégique, auparavant géré depuis les États-Unis.
+ Niveau élevé de coordination avec les équipes internationales des Relations avec les patients et des Affaires gouvernementales.
+ Collaboration interfonctionnelle avec les équipes des Affaires médicales, de l'Accès au marché, des Communications corporatives, des Affaires juridiques et de la Conformité.
+ Interaction externe avec les organisations de patients, les professionnels de la santé, les donneurs, les organismes de réglementation et les associations industrielles, en étroite coordination avec CBS.
**FONCTIONS ET RESPONSABILITÉS**
**1. Relations avec les patients (principal axe de responsabilité)**
+ Mettre en œuvre la stratégie internationale de relations avec les patients au Canada, en assurant une exécution locale solide et un impact mesurable.
+ Développer et maintenir des relations de confiance durables avec les organisations de patients et les parties prenantes clés.
+ Positionner Grifols comme un partenaire crédible, responsable et centré sur le patient au sein de l'écosystème canadien.
+ Identifier et mettre en œuvre des collaborations stratégiques, initiatives éducatives et programmes d'engagement des patients.
+ Recueillir, consolider et valoriser les perspectives et besoins des patients afin d'orienter les priorités internes et la prise de décision.
+ Représenter la voix du patient à l'interne, en assurant l'alignement avec l'approche mondiale des Relations avec les patients.
+ Coordonner les activités destinées aux patients (événements, comités consultatifs, partenariats et collaborations).
+ Veiller à ce que toutes les activités soient réalisées dans le plein respect des politiques internes et des réglementations externes.
Sensibilisation au plasma et lien « du donneur au patient » (Vein-to-Vein)
+ Piloter des initiatives visant à accroître la sensibilisation au don de plasma et à son impact vital.
+ Promouvoir le concept du lien « du donneur au patient » entre les donneurs de plasma et les patients.
+ Collaborer avec les centres de collecte, les organisations de patients et les autres parties prenantes afin de renforcer ce message à l'échelle locale.
+ Adapter et mettre en œuvre les meilleures pratiques provenant d'autres pays (par exemple l'Allemagne) dans le contexte canadien.
**2. Stratégie des Affaires corporatives et alignement interfonctionnel**
+ Élaborer et exécuter le plan local des Affaires corporatives, aligné sur la stratégie et les priorités internationales.
+ Assurer la cohérence du positionnement, des messages et de l'engagement des parties prenantes.
+ Agir comme principal lien entre les équipes du Canada et des Affaires corporatives internationales.
+ Contribuer au renforcement de la réputation de Grifols et à l'établissement d'une confiance durable auprès des parties prenantes.
**3. Affaires gouvernementales et politiques publiques (rôle de soutien avec évolution progressive des responsabilités)**
+ Assurer une veille et analyser le contexte réglementaire et politique canadien lié au plasma, aux médicaments dérivés du plasma et à l'accès aux soins de santé.
+ Soutenir la stratégie d'Affaires gouvernementales en coordination avec le siège social et les partenaires de coentreprise (CBS).
+ Interagir au besoin avec les décideurs publics, les organismes de réglementation et les intervenants de l'industrie.
+ Identifier les risques et les occasions ayant une incidence sur l'accès, la durabilité et l'innovation.
**4. Engagement des parties prenantes et représentation externe**
+ Développer et gérer les relations avec :
+ Les organisations de patients
+ Les professionnels de la santé
+ Les décideurs publics et les organismes de réglementation
+ Les associations de l'industrie et les ONG
+ Représenter Grifols dans les forums pertinents, associations professionnelles, groupes de travail et événements, lorsque requis.
**5. Veille, rapports et conformité**
+ Surveiller les tendances liées aux besoins des patients, aux évolutions des politiques publiques et aux attentes des parties prenantes.
+ Fournir des analyses locales et des recommandations stratégiques aux Affaires corporatives internationales.
+ Préparer des rapports réguliers sur les activités et les résultats obtenus.
+ Veiller au respect des normes de conformité, de transparence et d'éthique.
**EXPÉRIENCE**
+ Plus de 10 ans d'expérience.
+ Expérience en relations avec les patients, défense des intérêts des patients, affaires corporatives ou autres fonctions connexes dans le domaine de la santé.
+ Expérience démontrée dans l'établissement de partenariats avec des organisations de patients.
+ Une expérience en affaires gouvernementales ou affaires publiques constitue un atout important.
+ Une solide compréhension du système de santé canadien est fortement souhaitée.
**FORMATION ACADÉMIQUE**
+ Baccalauréat en sciences de la vie, santé publique, science politique, droit, économie ou dans un domaine connexe.
+ Maîtrise en politiques publiques, économie de la santé ou domaine similaire : un atout.
**LANGUES**
+ Anglais : langue maternelle ou niveau courant
+ Français : langue maternelle ou bilingue
+ Espagnol : un atout
**COMPÉTENCES FONCTIONNELLES**
+ Excellentes aptitudes en gestion des parties prenantes et en développement de partenariats.
+ Solides compétences en communication, influence et négociation.
+ Capacité à traduire une stratégie mondiale en une exécution locale efficace.
+ Forte capacité de réflexion stratégique combinée à une orientation vers l'exécution.
+ Capacité à évoluer dans des environnements ambigus et en constante évolution avec un haut degré d'autonomie.
**QUALITÉS PERSONNELLES ET COMPÉTENCES COMPORTEMENTALES**
+ Forte orientation patient et grande empathie.
+ Esprit proactif, orienté vers les solutions et capacité d'adaptation.
+ Haut niveau d'intégrité et forte sensibilité aux exigences de conformité.
+ Esprit collaboratif et aisance dans un contexte multiculturel.
+ Capacité à travailler de manière autonome tout en assurant un alignement constant avec le siège social.
**CANADA CORPORATE AFFAIRS DIRECTOR (GOVERNMENT & PATIENT AFFAIRS)**
**MISSION**
Grifols is a global healthcare company committed to advancing health outcomes through a patient-centered approach.
The Canada Corporate Affairs Director is responsible for establishing and consolidating Grifols' Corporate Affairs presence in Canada by driving the local implementation of the company's Patient Affairs strategy as a priority, while supporting Government Affairs initiatives in coordination with global and joint-venture partners (CBS).
The role will focus on building trusted patient partnerships, strengthening Grifols' reputation, and ensuring that patient needs and the value of Plasma-Derived Medicinal Products (PDMPs) are understood and appropriately reflected across the healthcare ecosystem, in full alignment with the company's international strategy and positioning.
This position will act as the local execution anchor and reporting to International Corporate Affairs, based in the company's HQ, translating global priorities into impactful, locally adapted initiatives within the Canadian healthcare ecosystem.
**ENVIRONMENT**
+ Newly created role in a strategic priority market, previously managed from the US
+ High level of coordination with International Patient & Government Affairs
+ Cross-functional collaboration with Medical Affairs, Market Access, Corporate Communications, Legal and Compliance
+ External engagement with patient organizations, healthcare professionals, donors, regulators, and industry associations in full coordination with CBS
**FUNCTIONS AND RESPONSIBILITIES**
**1. Patient Affairs (Primary Focus)**
+ Implement the International Patient Affairs strategy in Canada, ensuring strong local execution and measurable impact
+ Build and maintain trusted, long-term relationships with patient organizations and key stakeholders
+ Position Grifols as a credible and responsible patient-centric partner within the Canadian ecosystem
+ Identify and execute strategic collaborations, education initiatives, and patient engagement programs
+ Capture, consolidate and elevate patient insights to inform internal priorities and decision-making
+ Represent the patient perspective internally, ensuring alignment with global Patient Affairs approach
+ Coordinate patient-facing activities (events, advisory boards, partnerships, collaborations)
+ Ensure all activities are conducted in full compliance with internal policies and external regulations
**Plasma Awareness & Vein-to-Vein Connection**
+ Drive initiatives to increase awareness of plasma donation and its life-saving impact
+ Promote the "vein-to-vein" connection between plasma donors and patients
+ Collaborate with donor centers, patient organizations and stakeholders to strengthen this narrative locally
+ Adapt and implement best practices from other countries (e.g. Germany) into the Canadian context
**2. Corporate Affairs Strategy & Cross-functional Alignment**
+ Develop and execute the local Corporate Affairs plan aligned with International strategy and priorities
+ Ensure consistency in positioning, messaging and stakeholder engagement
+ Act as a key liaison between Canada and International Corporate Affairs
+ Contribute to strengthening Grifols' reputation and long-term stakeholder trust
**3. Government & Policy Affairs (Supporting Role/** **Progressive Responsibility)**
+ Monitor and analyze the Canadian policy and regulatory landscape relevant to plasma, PDMPs and healthcare access
+ Support Government Affairs strategy in coordination with HQ and joint-venture partners (CBS)
+ Engage with policymakers, regulators and industry stakeholders as needed
+ Identify risks and opportunities impacting access, sustainability and innovation
**4. Stakeholder Engagement & External Representation**
+ Build and manage relationships with:
+ Patient organizations
+ Healthcare professionals
+ Policymakers and regulators
+ Industry associations and NGOs
+ Represent Grifols in relevant forums, professional associations, working groups and events, when appropriate
**5. Insights, Reporting & Compliance**
+ Monitor trends in patient needs, policy developments and stakeholder expectations
+ Provide local insights and strategic input to International Corporate Affairs
+ Prepare regular reports on activities and outcomes
+ Ensure adherence to compliance, transparency and ethical standards
**EXPERIENCE**
+ Years of Experience: 10+ years
+ Experience in Patient Affairs, patient advocacy, Corporate Affairs or related healthcare roles
+ Proven track record in building partnerships with patient organizations
+ Exposure to Government or Public Affairs activities is a strong plus
+ Solid understanding of the Canadian healthcare system strongly preferred
**ACADEMIC BACKGROUND**
+ Bachelor's degree in Life Sciences, Public Health, Political Science, Law, Economics or related field
+ Master's degree in Public Policy, Health Economics or similar is a plus
**LANGUAGES**
+ English: Native/fluent
+ French: Native/bilingual
+ Spanish: Nice to have
**FUNCTIONAL SKILLS**
+ Strong stakeholder engagement and partnership-building capabilities
+ Excellent communication, influencing and negotiation skills
+ Ability to translate global strategy into effective local execution
+ Strong strategic thinking combined with execution focus
+ Ability to operate in ambiguous, evolving environments with high autonomy
**PERSONAL ATTRIBUTES & COMPETENCIES**
+ Strong patient-centric mindset and empathy
+ Proactive, solution-oriented and adaptable
+ High level of integrity and compliance awareness
+ Collaborative and cross-cultural mindset
+ Ability to operate autonomously while ensuring alignment with HQ
\#LI-AC1
Politique de confidentialité de Canada - Careers ( Careers Privacy Notice
**Location: NORTH AMERICA : Canada : Mississauga:CATORONT - Canada Headquarters - Toronto**
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:** GENERAL MANAGEMENT
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Spécialiste, système qualité & conformité Matériaux Quality System & Compliance Specialist Materials
Posted 4 days ago
Job Viewed
Job Description
Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
**Titre du poste :** Spécialiste, système qualité et conformité (Matériaux)
**Relève de :** Superviseur, système qualité et conformité - Matériaux
**Résumé :**
Le spécialiste, système qualité et conformité - matériaux, contribue activement à l'évaluation et à la qualification des matériaux et des fournisseurs au sein du département Système qualité et conformité. Il apporte une expertise technique dans le cadre de projets, d'audits et d'activités de conformité, tout en assurant le respect des exigences réglementaires et des normes internes. Il participe à la collecte et à l'analyse de données afin d'aider le département à prendre des décisions et peut participer à la formation technique et non technique. D'autres tâches peuvent lui être assignées selon les besoins.
**Principales responsabilités :**
+ Évaluer les matériaux et les fournisseurs conformément aux procédures établies. S'assurer que les matériaux sont conformes aux spécifications, aux exigences réglementaires et aux normes internes. Produire et examiner les rapports d'évaluation des materiaux.
+ Peut procéder à l'évaluation annuelle des fournisseurs qualifiés sur la base de critères de qualité, de conformité et de performance.
+ Participer aux évaluations des risques liés aux matériaux et aux fournisseurs.
+ Tenir à jour la liste des fournisseurs agréés et veiller à leur conformité continue.
+ Apporter son soutien aux inspections réglementaires et aux audits clients, si nécessaire.
+ Soutenir la gestion et l'amélioration continue des systèmes, programmes ou projets liés à la qualité.
+ Veiller au respect des politiques et procédures de l'entreprise dans le cadre de son domaine d'expertise.
+ Fournir des conseils techniques sur les questions liées à la qualité et à la conformité.
+ Collaborer avec les équipes de fabrication, de réglementation et de production sur les questions liées aux bonnes pratiques de fabrication (GxP).
+ Respecter les bonnes pratiques de fabrication (GMP) et les pratiques de sécurité du département.
+ Aider à la préparation de propositions et de recommandations à l'intention de la direction du département.
+ Peut enquêter et résoudre les problèmes de qualité liés aux matériaux et aux fournisseurs.
+ Rédiger et réviser les SOP et autres documents de qualité liés aux matériaux et aux fournisseurs.
+ Collaborer avec les départements de production, de contrôle qualité et autres sur des projets, des enquêtes sur les écarts, des CAPA, des contrôles des changements et des améliorations du système qualité.
+ Examiner et évaluer les notifications de changement fournisseur quant à leurs impacts qualité, réglementaires et opérationnels, et assurer la mise en œuvre et la documentation en temps opportun des actions requises.
**Qualifications requises :**
+ Baccalauréat en sciences, technologie, ingénierie ou mathématiques (STEM) ou expérience équivalente.
+ Minimum de 5 ans d'expérience pertinente dans le domaine de la qualité.
+ Expérience démontrée dans les systèmes qualité et la gestion de la qualité des matériaux ou de fournisseurs.
+ Excellentes compétences en communication écrite et orale.
+ Compréhension des exigences réglementaires et des lignes directrices nationales (p. ex. Santé Canada) et internationales (p. ex. FDA CFR) applicables.
+ Haut niveau d'intégrité et de rigueur professionnelle.
+ Bilinguisme français/anglais requis (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA)
+ Gère plusieurs tâches et établit efficacement les priorités afin de respecter les échéances
**Job Title:** Specialist, Quality System & Compliance (Materials)
**Reports to:** Supervisor, Quality System & Compliance - Materials
**Summary:**
The Specialist, Quality System & Compliance - Materials and Suppliers plays a key role in evaluating and qualifying materials and suppliers within the Quality System and Compliance department. This individual provides technical expertise in support of projects, audits, and compliance activities, ensuring adherence to regulatory requirements and internal standards. The specialist contributes to data collection and analysis to support departmental decision-making and may assist in delivering technical and non-technical training. Additional tasks may be assigned as needed.
**Key Responsibilities:**
+ Perform evaluation of materials and suppliers according to established procedures. Ensure materials meet specifications, regulatory requirements, and internal standards. Generate and review commodity evaluation reports.
+ May perform annual evaluation of qualified suppliers based on quality, compliance, and performance criteria.
+ Participate in risk assessments related to materials and suppliers.
+ Maintain the approved supplier list and ensure ongoing compliance.
+ May participate in internal and supplier audits.
+ Support regulatory inspections and customer audits as needed.
+ Support the management and continuous improvement of quality systems, programs, or projects.
+ Ensure compliance with company policies and procedures within the scope of expertise.
+ Provide technical guidance on quality and compliance-related matters.
+ Collaborate with manufacturing, Quality Control, Quality assurance, and production teams on GxP-related issues.
+ Adhere to GMP and departmental safety practices.
+ Assist in preparing proposals and recommendations for the department's leadership.
+ May investigate and resolve quality issues related to materials and suppliers.
+ Draft and revise SOPs and other quality documents related to materials and suppliers.
+ Collaborate with production, quality control, and other departments on projects, deviation investigations, CAPAs, change controls, and quality system improvements.
+ Review and evaluate Supplier Change Notifications for quality, regulatory, and operational impact, and drive timely implementation and documentation of required actions
**Required Qualifications:**
+ Bachelor's degree in a STEM field (Science, Technology, Engineering, Mathematics) or equivalent combination of education and experience.
+ Minimum of 5 years of relevant experience in quality systems.
+ Demonstrated experience in supplier and material qualification.
+ Strong written and verbal communication skills.
+ Understanding of applicable national (e.g., Health Canada) and international (e.g., FDA CFR) regulatory requirements and guidelines.
+ High level of integrity and professionalism.
+ Bilingual in French and English (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA)
+ Manages multiple tasks, prioritizes effectively to meet deadlines
Politique de confidentialité de Canada - Careers ( Careers Privacy Notice
**Location: NORTH AMERICA : Canada : Montreal:CAQUEBEC - Quebec**
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:** TECHNICAL
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
**Titre du poste :** Spécialiste, système qualité et conformité (Matériaux)
**Relève de :** Superviseur, système qualité et conformité - Matériaux
**Résumé :**
Le spécialiste, système qualité et conformité - matériaux, contribue activement à l'évaluation et à la qualification des matériaux et des fournisseurs au sein du département Système qualité et conformité. Il apporte une expertise technique dans le cadre de projets, d'audits et d'activités de conformité, tout en assurant le respect des exigences réglementaires et des normes internes. Il participe à la collecte et à l'analyse de données afin d'aider le département à prendre des décisions et peut participer à la formation technique et non technique. D'autres tâches peuvent lui être assignées selon les besoins.
**Principales responsabilités :**
+ Évaluer les matériaux et les fournisseurs conformément aux procédures établies. S'assurer que les matériaux sont conformes aux spécifications, aux exigences réglementaires et aux normes internes. Produire et examiner les rapports d'évaluation des materiaux.
+ Peut procéder à l'évaluation annuelle des fournisseurs qualifiés sur la base de critères de qualité, de conformité et de performance.
+ Participer aux évaluations des risques liés aux matériaux et aux fournisseurs.
+ Tenir à jour la liste des fournisseurs agréés et veiller à leur conformité continue.
+ Apporter son soutien aux inspections réglementaires et aux audits clients, si nécessaire.
+ Soutenir la gestion et l'amélioration continue des systèmes, programmes ou projets liés à la qualité.
+ Veiller au respect des politiques et procédures de l'entreprise dans le cadre de son domaine d'expertise.
+ Fournir des conseils techniques sur les questions liées à la qualité et à la conformité.
+ Collaborer avec les équipes de fabrication, de réglementation et de production sur les questions liées aux bonnes pratiques de fabrication (GxP).
+ Respecter les bonnes pratiques de fabrication (GMP) et les pratiques de sécurité du département.
+ Aider à la préparation de propositions et de recommandations à l'intention de la direction du département.
+ Peut enquêter et résoudre les problèmes de qualité liés aux matériaux et aux fournisseurs.
+ Rédiger et réviser les SOP et autres documents de qualité liés aux matériaux et aux fournisseurs.
+ Collaborer avec les départements de production, de contrôle qualité et autres sur des projets, des enquêtes sur les écarts, des CAPA, des contrôles des changements et des améliorations du système qualité.
+ Examiner et évaluer les notifications de changement fournisseur quant à leurs impacts qualité, réglementaires et opérationnels, et assurer la mise en œuvre et la documentation en temps opportun des actions requises.
**Qualifications requises :**
+ Baccalauréat en sciences, technologie, ingénierie ou mathématiques (STEM) ou expérience équivalente.
+ Minimum de 5 ans d'expérience pertinente dans le domaine de la qualité.
+ Expérience démontrée dans les systèmes qualité et la gestion de la qualité des matériaux ou de fournisseurs.
+ Excellentes compétences en communication écrite et orale.
+ Compréhension des exigences réglementaires et des lignes directrices nationales (p. ex. Santé Canada) et internationales (p. ex. FDA CFR) applicables.
+ Haut niveau d'intégrité et de rigueur professionnelle.
+ Bilinguisme français/anglais requis (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA)
+ Gère plusieurs tâches et établit efficacement les priorités afin de respecter les échéances
**Job Title:** Specialist, Quality System & Compliance (Materials)
**Reports to:** Supervisor, Quality System & Compliance - Materials
**Summary:**
The Specialist, Quality System & Compliance - Materials and Suppliers plays a key role in evaluating and qualifying materials and suppliers within the Quality System and Compliance department. This individual provides technical expertise in support of projects, audits, and compliance activities, ensuring adherence to regulatory requirements and internal standards. The specialist contributes to data collection and analysis to support departmental decision-making and may assist in delivering technical and non-technical training. Additional tasks may be assigned as needed.
**Key Responsibilities:**
+ Perform evaluation of materials and suppliers according to established procedures. Ensure materials meet specifications, regulatory requirements, and internal standards. Generate and review commodity evaluation reports.
+ May perform annual evaluation of qualified suppliers based on quality, compliance, and performance criteria.
+ Participate in risk assessments related to materials and suppliers.
+ Maintain the approved supplier list and ensure ongoing compliance.
+ May participate in internal and supplier audits.
+ Support regulatory inspections and customer audits as needed.
+ Support the management and continuous improvement of quality systems, programs, or projects.
+ Ensure compliance with company policies and procedures within the scope of expertise.
+ Provide technical guidance on quality and compliance-related matters.
+ Collaborate with manufacturing, Quality Control, Quality assurance, and production teams on GxP-related issues.
+ Adhere to GMP and departmental safety practices.
+ Assist in preparing proposals and recommendations for the department's leadership.
+ May investigate and resolve quality issues related to materials and suppliers.
+ Draft and revise SOPs and other quality documents related to materials and suppliers.
+ Collaborate with production, quality control, and other departments on projects, deviation investigations, CAPAs, change controls, and quality system improvements.
+ Review and evaluate Supplier Change Notifications for quality, regulatory, and operational impact, and drive timely implementation and documentation of required actions
**Required Qualifications:**
+ Bachelor's degree in a STEM field (Science, Technology, Engineering, Mathematics) or equivalent combination of education and experience.
+ Minimum of 5 years of relevant experience in quality systems.
+ Demonstrated experience in supplier and material qualification.
+ Strong written and verbal communication skills.
+ Understanding of applicable national (e.g., Health Canada) and international (e.g., FDA CFR) regulatory requirements and guidelines.
+ High level of integrity and professionalism.
+ Bilingual in French and English (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA)
+ Manages multiple tasks, prioritizes effectively to meet deadlines
Politique de confidentialité de Canada - Careers ( Careers Privacy Notice
**Location: NORTH AMERICA : Canada : Montreal:CAQUEBEC - Quebec**
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:** TECHNICAL
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8
Spécialiste en Instrumentation, Contrôle qualité - Quality Control Instrumentation Specialist
Posted 4 days ago
Job Viewed
Job Description
Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
**Poste:** Spécialiste en Instrumentation, Contrôle qualité
**Relève de:** Gestionnaire, contrôle qualité
**Sommaire du poste :**
Le spécialiste en instrumentation au contrôle de Qualité (QC) est responsable de soutenir la qualification des instruments de laboratoire et des unités à température contrôlée (réfrigérateurs, congélateurs et incubateurs) et de coordonner les programmes d'entretien et d'étalonnage de ces instruments et unités pour le département de Contrôle qualité de Grifols Canada Thérapeutiques. Les responsabilités de ce poste nécessitent une solide expérience en instrumentation de laboratoire.
**Tâches et responsabilités:**
+ Installation, maintenance, diagnostic et dépannage des équipements analytiques du laboratoire (TOC, HPLC, GC, IR, UV-VIS, IC, Karl Fischer, MALDI Biotyper, Endotoxin System, ELISA).
+ Maintient et examine les données d'étalonnage associées aux instruments et rapporter les changements dans les performances.
+ Fournit l'expertise requise pour gérer les qualifications d'installation/de fonctionnement et de performance des instruments de laboratoire de contrôle qualité
+ Aide à la rédaction des rapports IQ/OQ/PQ et de validation pour les instruments du Laboratoire
+ Développer et/ou mettre à jour les procédures de calibration et d'étalonnage des équipements
+ Assiste le département QC pour mener toute investigation reliée aux instruments et aux unités à température contrôlées
+ Avertir le responsable du laboratoire QC de tout problème de qualité potentiel lié aux instruments et aux unités de températures contrôlées de laboratoire et fournit des recommandations pour l'amélioration de la qualité
+ Aide à instaurer les actions correctives reliées aux observations d'audit liées aux validations des instruments.
+ Coordination de la calibration et maintenance des instruments et de l'inventaire des pièces de rechange ainsi que la coordination avec les fournisseurs.
+ Connaissance avancée de gestion de la maintenance via SAP pour recueillir des informations concernant les étalonnages et les maintenances préventives.
**Qualifications:**
+ B.Sc. (de préférence) en biochimie, en physique ou dans un domaine des sciences de la vie
+ Ayant au moins six ans d'expérience dans le même poste dans un laboratoire de contrôle de la qualité dans un environnement cGMP dans l'industrie pharmaceutique ou biotechnologique.
+ Solides compétences en communication, en relations interpersonnelles, en organisation et en prise de décision. Solides compétences en rédaction technique Nécessite un niveau avancé de connaissances et de compétences pour les systèmes informatisés utilisés avec l'équipement de laboratoire.
+ Connaissance des BPF ainsi que des pharmacopées (USP, BP, EP) pour supporter les produits destinés aux marchés canadien, américain et européen.
+ Connaissance avancée de la qualification des Système informatisé analytique, des exigences d'intégrité des données et de la validation des systèmes informatiques pour les applications des systèmes de laboratoire.
+ Compétences en MS Office (Excel, Word et Power point) et solide expérience des logiciels des systèmes liés aux applications pharmaceutiques.
+ Bilinguisme en français et anglais de préférence (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA).
**Position Title:** QC Instrumentation Specialist
**Reports to:** QC Manager
**Position Summary**
The QC Instrumentation Specialist is responsible for supporting the qualification of laboratory instruments and to coordinate the maintenance and calibration programs for systems and Controlled temperature unit (Fridges, Freezers, and Incubators) in operation at the QC Laboratories at Grifols Canada Therapeutics Inc. The responsibilities for this position require a strong background in laboratory instrumentation to support QC laboratory systems and Equipment Activities.
**Key Duties and Responsibilities**
+ Installation, maintenance, diagnosis and troubleshooting of the laboratory analytical equipment (TOC, HPLC, GC, IR, UV-VIS, IC, Karl Fischer , MALDI Biotyper , Endotoxin System, ELISA).
+ Maintains and reviews calibration data associated with QC laboratory standards and trends changes in standard or assay performance.
+ Provides the expertise required to generate installation/operation/performance qualifications for sophisticated QC laboratory instrumentation
+ Help to Generates IQ/OQ/PQ and validation reports for QC instrumentation
+ Develop or update Calibration Standard Procedures
+ Assists the QC department in troubleshooting or investigating instrument
+ Notifies QC management of any potential quality issues related to Lab instrumentations and provide recommendations for quality improvement
+ Assists in the resolution of audit observations related to validations and proposes corrective actions.
+ Coordination of the instrument maintenance and spare parts inventory as well as coordination with vendors.
+ Use computers and or Advanced Maintenance Management System (SAP) to gather information for analysis regarding calibrations and Preventive maintenances
**Qualifications:**
+ B.Sc. (preferred) in Biochemistry, Physics, or a Life Sciences field
+ Requires at least six years of experience working in the same position in a Quality Control laboratory in a cGMP environment such as is found in the pharmaceutical or biotech industry.
+ Experience in an FDA regulated manufacturing facility - pharmaceutical, biologics, biotech, with knowledge of cGMPs, FDA regulations, and industry guidelines is preferred. Experience in Q is a plus. Knowledge of calibration, quality control instrumentation, must have strong trouble shooting abilities to identify and resolve equipment problems. Able to repair, calibrate, install.
+ Strong communication, interpersonal, organizational, and decision-making skills. Strong technical writing skills. Requires a fundamental understanding of analytical methodology, protein biochemistry, immunochemistry, chromatography, electrophoresis, spectroscopy, and ELISA. Requires an advanced knowledge and skill level for computerized systems used with laboratory equipment.
+ Knowledge of GMP as well as pharmacopeia (USP, BP, EP) to support products intended for the Canadian, US and European markets.
+ Advanced knowledge of automated and computerized systems qualification, data integrity requirements and computer system validation for lab system applications.
+ Expert level MS Office skills and solid experience with IT systems related to pharmaceutical applications.
+ Bilingualism in French and English preferred (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA)
Politique de confidentialité de Canada - Careers ( Careers Privacy Notice
**Location: NORTH AMERICA : Canada : Montreal:CAQUEBEC - Quebec**
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:** TECHNICAL
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
**Poste:** Spécialiste en Instrumentation, Contrôle qualité
**Relève de:** Gestionnaire, contrôle qualité
**Sommaire du poste :**
Le spécialiste en instrumentation au contrôle de Qualité (QC) est responsable de soutenir la qualification des instruments de laboratoire et des unités à température contrôlée (réfrigérateurs, congélateurs et incubateurs) et de coordonner les programmes d'entretien et d'étalonnage de ces instruments et unités pour le département de Contrôle qualité de Grifols Canada Thérapeutiques. Les responsabilités de ce poste nécessitent une solide expérience en instrumentation de laboratoire.
**Tâches et responsabilités:**
+ Installation, maintenance, diagnostic et dépannage des équipements analytiques du laboratoire (TOC, HPLC, GC, IR, UV-VIS, IC, Karl Fischer, MALDI Biotyper, Endotoxin System, ELISA).
+ Maintient et examine les données d'étalonnage associées aux instruments et rapporter les changements dans les performances.
+ Fournit l'expertise requise pour gérer les qualifications d'installation/de fonctionnement et de performance des instruments de laboratoire de contrôle qualité
+ Aide à la rédaction des rapports IQ/OQ/PQ et de validation pour les instruments du Laboratoire
+ Développer et/ou mettre à jour les procédures de calibration et d'étalonnage des équipements
+ Assiste le département QC pour mener toute investigation reliée aux instruments et aux unités à température contrôlées
+ Avertir le responsable du laboratoire QC de tout problème de qualité potentiel lié aux instruments et aux unités de températures contrôlées de laboratoire et fournit des recommandations pour l'amélioration de la qualité
+ Aide à instaurer les actions correctives reliées aux observations d'audit liées aux validations des instruments.
+ Coordination de la calibration et maintenance des instruments et de l'inventaire des pièces de rechange ainsi que la coordination avec les fournisseurs.
+ Connaissance avancée de gestion de la maintenance via SAP pour recueillir des informations concernant les étalonnages et les maintenances préventives.
**Qualifications:**
+ B.Sc. (de préférence) en biochimie, en physique ou dans un domaine des sciences de la vie
+ Ayant au moins six ans d'expérience dans le même poste dans un laboratoire de contrôle de la qualité dans un environnement cGMP dans l'industrie pharmaceutique ou biotechnologique.
+ Solides compétences en communication, en relations interpersonnelles, en organisation et en prise de décision. Solides compétences en rédaction technique Nécessite un niveau avancé de connaissances et de compétences pour les systèmes informatisés utilisés avec l'équipement de laboratoire.
+ Connaissance des BPF ainsi que des pharmacopées (USP, BP, EP) pour supporter les produits destinés aux marchés canadien, américain et européen.
+ Connaissance avancée de la qualification des Système informatisé analytique, des exigences d'intégrité des données et de la validation des systèmes informatiques pour les applications des systèmes de laboratoire.
+ Compétences en MS Office (Excel, Word et Power point) et solide expérience des logiciels des systèmes liés aux applications pharmaceutiques.
+ Bilinguisme en français et anglais de préférence (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA).
**Position Title:** QC Instrumentation Specialist
**Reports to:** QC Manager
**Position Summary**
The QC Instrumentation Specialist is responsible for supporting the qualification of laboratory instruments and to coordinate the maintenance and calibration programs for systems and Controlled temperature unit (Fridges, Freezers, and Incubators) in operation at the QC Laboratories at Grifols Canada Therapeutics Inc. The responsibilities for this position require a strong background in laboratory instrumentation to support QC laboratory systems and Equipment Activities.
**Key Duties and Responsibilities**
+ Installation, maintenance, diagnosis and troubleshooting of the laboratory analytical equipment (TOC, HPLC, GC, IR, UV-VIS, IC, Karl Fischer , MALDI Biotyper , Endotoxin System, ELISA).
+ Maintains and reviews calibration data associated with QC laboratory standards and trends changes in standard or assay performance.
+ Provides the expertise required to generate installation/operation/performance qualifications for sophisticated QC laboratory instrumentation
+ Help to Generates IQ/OQ/PQ and validation reports for QC instrumentation
+ Develop or update Calibration Standard Procedures
+ Assists the QC department in troubleshooting or investigating instrument
+ Notifies QC management of any potential quality issues related to Lab instrumentations and provide recommendations for quality improvement
+ Assists in the resolution of audit observations related to validations and proposes corrective actions.
+ Coordination of the instrument maintenance and spare parts inventory as well as coordination with vendors.
+ Use computers and or Advanced Maintenance Management System (SAP) to gather information for analysis regarding calibrations and Preventive maintenances
**Qualifications:**
+ B.Sc. (preferred) in Biochemistry, Physics, or a Life Sciences field
+ Requires at least six years of experience working in the same position in a Quality Control laboratory in a cGMP environment such as is found in the pharmaceutical or biotech industry.
+ Experience in an FDA regulated manufacturing facility - pharmaceutical, biologics, biotech, with knowledge of cGMPs, FDA regulations, and industry guidelines is preferred. Experience in Q is a plus. Knowledge of calibration, quality control instrumentation, must have strong trouble shooting abilities to identify and resolve equipment problems. Able to repair, calibrate, install.
+ Strong communication, interpersonal, organizational, and decision-making skills. Strong technical writing skills. Requires a fundamental understanding of analytical methodology, protein biochemistry, immunochemistry, chromatography, electrophoresis, spectroscopy, and ELISA. Requires an advanced knowledge and skill level for computerized systems used with laboratory equipment.
+ Knowledge of GMP as well as pharmacopeia (USP, BP, EP) to support products intended for the Canadian, US and European markets.
+ Advanced knowledge of automated and computerized systems qualification, data integrity requirements and computer system validation for lab system applications.
+ Expert level MS Office skills and solid experience with IT systems related to pharmaceutical applications.
+ Bilingualism in French and English preferred (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA)
Politique de confidentialité de Canada - Careers ( Careers Privacy Notice
**Location: NORTH AMERICA : Canada : Montreal:CAQUEBEC - Quebec**
Learn more about Grifols ( ID:**
**Type:** Regular Full-Time
**Job Category:** TECHNICAL
Is this job a match or a miss?
Apply Now
9